Diabetic NeuropathiesPhase 4NCT00844194
Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder
A Phase 4 study testing Duloxetine 60 mg QD, Duloxetine 30 mg QD and Duloxetine 90 mg QD in people with Diabetic Neuropathies and Depressive Disorder, Major, run by Boehringer Ingelheim at 25 sites in Germany.
Trial summary
The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies, Depressive Disorder, Major
- What is being tested?
- Duloxetine 60 mg QD, Duloxetine 30 mg QD and Duloxetine 90 mg QD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 25 sitesGermany
- Study dates
- Feb 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
- To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
- Male or female outpatients at least 18 years of age.
- Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
- Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
- Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Who cannot join
- Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
- Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
- Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
- Have previously been treated with duloxetine (for DPNP or MDD)
- Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II).
- Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Germany25 sites
1208.34.49008 Boehringer Ingelheim Investigational Site
Achim Bei Bremen
1208.34.49025 Boehringer Ingelheim Investigational Site
Aschaffenburg
1208.34.49001 Boehringer Ingelheim Investigational Site
Bad Mergentheim
1208.34.49018 Boehringer Ingelheim Investigational Site
Baesweiler
1208.34.49002 Boehringer Ingelheim Investigational Site
Berlin
1208.34.49005 Boehringer Ingelheim Investigational Site
Berlin
1208.34.49009 Boehringer Ingelheim Investigational Site
Berlin
1208.34.49021 Boehringer Ingelheim Investigational Site
Bremen
1208.34.49028 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1208.34.49012 Boehringer Ingelheim Investigational Site
Gera
1208.34.49004 Boehringer Ingelheim Investigational Site
Hamburg
1208.34.49020 Boehringer Ingelheim Investigational Site
Hamburg
1208.34.49023 Boehringer Ingelheim Investigational Site
Hamburg
1208.34.49015 Boehringer Ingelheim Investigational Site
Hattingen
1208.34.49027 Boehringer Ingelheim Investigational Site
Heidenheim
1208.34.49016 Boehringer Ingelheim Investigational Site
Kelkheim
1208.34.49006 Boehringer Ingelheim Investigational Site
Limburgerhof
1208.34.49022 Boehringer Ingelheim Investigational Site
Münster
1208.34.49019 Boehringer Ingelheim Investigational Site
Neuwied
1208.34.49024 Boehringer Ingelheim Investigational Site
Saint Ingberg
1208.34.49007 Boehringer Ingelheim Investigational Site
Steglitz
1208.34.49010 Boehringer Ingelheim Investigational Site
Stuhr
1208.34.49013 Boehringer Ingelheim Investigational Site
Unterhaching
1208.34.49029 Boehringer Ingelheim Investigational Site
Wiesbaden
1208.34.49026 Boehringer Ingelheim Investigational Site
Wuppertal
About this study
Official title: A 12 Weeks Open Label Two Parallel Groups Study to Assess the Efficacy of Orally Administered Duloxetine 60 mg and 120 mg Per Day on Treatment Outcomes in Patients With Diabetic Peripheral Neuropathic Pain With and Without Co-morbid Major Depressive Disorder. The Primary Objective of This Study is to Evaluate Whether the Efficacy of Duloxetine Given as 60 mg to 120 mg Once Daily (QD), Measured by the BPI Interference Score After 12 Weeks Shows a Clinically Relevant Improvement in the DPNP Patients With Co-morbid MDD
The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis.
As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain.
Read more
The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI).
As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale.
Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated.
To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.
- Conditions
- Diabetic Neuropathies, Depressive Disorder, Major
- Being tested
- Duloxetine 60 mg QD, Duloxetine 30 mg QD, Duloxetine 90 mg QD, Duloxetine 120 mg QD
- Medical subject headings
- Diabetic Neuropathies, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 60 mg QDDrug
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
Duloxetine 60 mg QDDrug
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
Duloxetine 30 mg QDDrug
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
Duloxetine 30 mg QDDrug
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
Duloxetine 90 mg QDDrug
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
Duloxetine 90 mg QDDrug
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
Duloxetine 60 mg QDDrug
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
Duloxetine 60 mg QDDrug
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
Duloxetine 120 mg QDDrug
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
Duloxetine 30 mg QDDrug
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
Duloxetine 30 mg QDDrug
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
Duloxetine 120 mg QDDrug
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
| Study group | Role | What they receive |
|---|---|---|
| DPNP with depression (1) | Other | Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6) Receives: Drug: Duloxetine 60 mg QD; Drug: Duloxetine 30 mg QD |
| DPNP with depression (2) | Other | Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6) Receives: Drug: Duloxetine 90 mg QD; Drug: Duloxetine 60 mg QD; Drug: Duloxetine 30 mg QD; Drug: Duloxetine 120 mg QD |
| DPNP without depression (1) | Other | Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6) Receives: Drug: Duloxetine 60 mg QD; Drug: Duloxetine 30 mg QD |
| DPNP without depression (2) | Other | Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6) Receives: Drug: Duloxetine 90 mg QD; Drug: Duloxetine 60 mg QD; Drug: Duloxetine 120 mg QD; Drug: Duloxetine 30 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Secondary outcomes (97)
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in BPI Worst Pain During Treatment From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 2
Change in Worst Pain (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 6
Change in Worst Pain (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 12
Change in Least Pain (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 2
Change in Least Pain During Treatment (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 6
Change in Least Pain (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 12
Change in Average Pain (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 2
Change in Average Pain During Treatment (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 6
Change in Average Pain (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 12
Number of Patients With a Reduction in BPI Average Pain at Week 2
Measured: Baseline and Week 2
Number of Patients With a Reduction in BPI Average Pain at Week 6
Measured: Baseline and Week 6
Number of Patients With a Reduction in BPI Average Pain at Week 12
Measured: Baseline and Week 12
Change in Pain During Treatment (BPI) From Baseline to Week 2
The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 2
Change in Pain (BPI) From Baseline to Week 6
The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 6
Change in Pain During Treatment (BPI) From Baseline to Week 12
The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Measured: Baseline and Week 12
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2
The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).
Measured: Baseline and Week 2
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6
The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).
Measured: Baseline and Week 6
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12
The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).
Measured: Baseline and Week 12
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Change in Interference of Pain With Mood (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With Mood (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With Mood (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 2
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 6
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Measured: Baseline and Week 12
Patient Global Impression - Improvement (PGI-I) at Week 2
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: Baseline and Week 2
Patient Global Impression - Improvement (PGI-I) at Week 6
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: Baseline and Week 6
Patient Global Impression - Improvement (PGI-I) at Week 12
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: Baseline and Week 12
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.
Measured: Baseline and Week 2
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.
Measured: Baseline and Week 6
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.
Measured: Baseline and Week 12
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).
Measured: Baseline and Week 2
Change in HADS Anxiety Total Score From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).
Measured: Baseline and Week 6
Change in HADS Anxiety Total Score From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).
Measured: Baseline and Week 12
Change in HADS Depression Total Score From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).
Measured: Baseline and Week 2
Change in HADS Depression Total Score From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).
Measured: Baseline and Week 6
Change in HADS Depression Total Score From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).
Measured: Baseline and Week 12
Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.
Measured: Baseline and Week 6
Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.
Measured: Baseline and Week 12
Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.
Measured: Baseline and Week 6
Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6
Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12
Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6
Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12
Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6
Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12
Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6
Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12
Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6
Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12
Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6
Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12
Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6
Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12
Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6
Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12
Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6
Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12
Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6
Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12
Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6
Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12
Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Measured: Baseline and Week 12
Change in Clinical Global Impression - Severity Pain From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).
Measured: Baseline and Week 2
Change in Clinical Global Impression - Severity Pain From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).
Measured: Baseline and Week 6
Change in Clinical Global Impression - Severity Pain From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).
Measured: Baseline and Week 12
Change in Hamilton Depression Score From Baseline to Week 2
The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.
Measured: Baseline and Week 2
Change in Hamilton Depression Score From Baseline to Week 6
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.
Measured: Baseline and Week 6
Change in Hamilton Depression Score From Baseline to Week 12
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.
Measured: Baseline and Week 12
Suicidal Thoughts by BDI-II at Week 2
Measured: Week 2
Suicidal Thoughts by BDI-II at Week 6
Measured: Week 6
Suicidal Thoughts by BDI-II at Week 12
Measured: Week 12
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2
Measured: Week 2
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6
Measured: Week 6
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12
Measured: Week 12
Change of Fasting Blood Glucose From Baseline at Week 12
Ancova analysis controlling for baseline and insulin intake
Measured: Baseline and Week 12
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12
Ancova analysis controlling for baseline and insulin intake
Measured: Baseline and Week 12
Change of Systolic Blood Pressure From Baseline at Week 12
Measured: Baseline and Week 12
Change of Diastolic Blood Pressure From Baseline at Week 12
Measured: Baseline and Week 12
Change of Pulse Rate From Baseline at Week 12
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844194
- Sponsor's protocol ID
- 1208.34
- Other IDs
- 2008-002731-32, 2008
- Status last verified
- Dec 2013
- First submitted
- 13 Feb 2009
- Last updated
- 15 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks Open Label Two Parallel Groups Study to Assess the Efficacy of Orally Administered Duloxetine 60 mg and 120 mg Per Day on Treatment Outcomes in Patients With Diabetic Peripheral Neuropathic Pain With and Without Co-morbid Major Depressive Disorder. The Primary Objective of This Study is to Evaluate Whether the Efficacy of Duloxetine Given as 60 mg to 120 mg Once Daily (QD), Measured by the BPI Interference Score After 12 Weeks Shows a Clinically Relevant Improvement in the DPNP Patients With Co-morbid MDD
- ClinicalTrials.gov ID
- NCT00844194
- Acronym / sponsor ID
- 1208.34
- Conditions
- Diabetic Neuropathies, Depressive Disorder, Major
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Posted 31 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis.
As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain.
The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI).
As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale.
Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated.
To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DPNP with depression (1) | Other | Drug: Duloxetine 60 mg QD, Drug: Duloxetine 30 mg QDPatients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6) |
| DPNP with depression (2) | Other | Drug: Duloxetine 90 mg QD, Drug: Duloxetine 60 mg QD, Drug: Duloxetine 30 mg QD, Drug: Duloxetine 120 mg QDPatients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6) |
| DPNP without depression (1) | Other | Drug: Duloxetine 60 mg QD, Drug: Duloxetine 30 mg QDPatients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6) |
| DPNP without depression (2) | Other | Drug: Duloxetine 90 mg QD, Drug: Duloxetine 60 mg QD, Drug: Duloxetine 120 mg QD, Drug: Duloxetine 30 mg QDPatients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
- To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
- Male or female outpatients at least 18 years of age.
- Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
- Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
Key exclusion criteria (6 listed)
- Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
- Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
- Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
- Have previously been treated with duloxetine (for DPNP or MDD)
- Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine 60 mg QDgiven to (1) all patients week 2-6; (2) all responders of both arms week 7-12 | Drug | DPNP without depression (1) |
| Duloxetine 60 mg QDgiven to (1) all patients week 2-6; (2) all responders of both arms week 7-12 | Drug | DPNP with depression (1) |
| Duloxetine 30 mg QDgiven to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks) | Drug | DPNP without depression (1) |
| Duloxetine 30 mg QDgiven to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks) | Drug | DPNP with depression (1) |
| Duloxetine 90 mg QDgiven to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD | Drug | DPNP with depression (2) |
| Duloxetine 90 mg QDgiven to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD | Drug | DPNP without depression (2) |
| Duloxetine 60 mg QDgiven to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down | Drug | DPNP without depression (2) |
| Duloxetine 60 mg QDgiven to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down | Drug | DPNP with depression (2) |
| Duloxetine 120 mg QDgiven to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated | Drug | DPNP without depression (2) |
| Duloxetine 30 mg QDgiven to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down) | Drug | DPNP without depression (2) |
| Duloxetine 30 mg QDgiven to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down) | Drug | DPNP with depression (2) |
| Duloxetine 120 mg QDgiven to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated | Drug | DPNP with depression (2) |
Primary outcome
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
Time frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
97 secondary outcomes
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6
Time frame: Baseline and Week 6
Change in BPI Worst Pain During Treatment From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Worst Pain (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Worst Pain (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Least Pain (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Least Pain During Treatment (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Least Pain (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Average Pain (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Average Pain During Treatment (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Average Pain (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Number of Patients With a Reduction in BPI Average Pain at Week 2
Time frame: Baseline and Week 2
Number of Patients With a Reduction in BPI Average Pain at Week 6
Time frame: Baseline and Week 6
Number of Patients With a Reduction in BPI Average Pain at Week 12
Time frame: Baseline and Week 12
Change in Pain During Treatment (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Pain (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Pain During Treatment (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2
Time frame: Baseline and Week 2
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6
Time frame: Baseline and Week 6
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With Mood (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With Mood (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With Mood (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2
Time frame: Baseline and Week 2
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6
Time frame: Baseline and Week 6
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine 60 mg QD, Duloxetine 30 mg QD and Duloxetine 90 mg QD in people with Diabetic Neuropathies and Depressive Disorder, Major, run by Boehringer Ingelheim at 25 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.