Diabetic Neuropathy, PainfulPhase 3COMBO-DNNCT01089556
A Study in Painful Diabetic Neuropathy
A Phase 3 study testing Duloxetine and Pregabalin in people with Diabetic Neuropathy, Painful, run by Eli Lilly and Company at 54 sites in 16 countries.
Trial summary
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Duloxetine and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 811 participants
- Where
- 54 sitesin 16 countries
- Study dates
- Mar 2010to Nov 2011
- Phase
- Phase 3
- 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
- Pain due to bilateral peripheral neuropathy (caused by type 1 or type 2 diabetes mellitus. Pain must begin in the feet, with relatively symmetrical onset. Daily pain should be present for more than 3 months [assessed by questioning patient]).
- Score of at least 4 on the 24-hour average pain severity score on an 11-point Likert scale [on Brief Pain Inventory (BPI) Modified Short Form] at screening and at randomization.
- Patient is currently not receiving treatment for diabetic peripheral neuropathic pain (DPNP) or was receiving treatment for DPNP, with a drug other than pregabalin or duloxetine, and completed the required washout
- Patient has never received treatment with duloxetine or pregabalin. (However, a short course of less than 15 days of treatment, at any time previously, will be allowed.)
- Stable glycemic control, as assessed by a physician investigator, and hemoglobin A1c (HbA1c) less than or equal to 12% at screening.
Who cannot join
- Have a known hypersensitivity to duloxetine or pregabalin or any of the inactive ingredients or have any contraindication for the use of duloxetine or pregabalin.
- Have uncontrolled narrow-angle glaucoma.
- Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization, or have a potential need to use a MAOI during the study or within 5 days after discontinuation of study drug.
- Have received fluoxetine within 30 days prior to randomization.
- Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
- Have a serum creatinine greater than or equal to 1.5 milligram per deciliter (mg/dL) or a creatinine clearance less than 60 milliliter per minute (mL/min), at screening.
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- Are judged clinically by the investigator to be at suicidal risk or as defined by a score of 2 or greater on Question 9 of the Beck Depression Inventory-II (BDI-II), at screening or randomization
- Have a historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.
- Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the DPNP.
- Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; a history of seizure disorder; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
- Have received non-pharmacological treatment for pain within 14 days prior to randomization, or do not agree to abstain from non-pharmacological treatment during the study.
- Have a history of frequent and/or severe allergic reactions with multiple medications.
Trial locations and contacts
54 sites in 16 countries.
54 sites in 16 countries
France9 sites
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Angers, 49933
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Bourges, 18000
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Juan-les-Pins, 06600
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Nevers, 58000
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Nîmes, 30029
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Paris, 75018
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Valenciennes, 59322
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Vierzon, 18100
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Vieux-Condé, 59690
Canada6 sites
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Cambridge, Ontario, N1R 7L6
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Halifax, Nova Scotia, B3H 3A7
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Kelowna, British Columbia, V1Y 1Z9
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Laval, Quebec, H7T 2P5
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Vancouver, British Columbia, V6H 3X8
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Winnipeg, Manitoba, R3P 3P4
United Kingdom6 sites
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Ashton-under-Lyne, Ashton-Under-Lyne, OL6 9RW
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Ayrshire, Scotland, KA6 6DX
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Chorley, Chorley, PR7 1PP
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Livingston, West Lothian, EH54 6PP
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Manchester, Greater Manchester, M13 0JE
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Nuneaton, Warwickshire, CV10 7BL
Croatia4 sites
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Osijek, 31000
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Rijeka, HR-51000
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Varaždin, 42000
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Zagreb, 10000
Italy4 sites
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Catania, 95100
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Milan, 20162
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Naples, 80131
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Rome, 00161
Poland4 sites
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Bialystok, 15-445
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Lublin, 20-538
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Szczecin, 70-506
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Wroclaw, 50-127
Sweden4 sites
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Falköping, SE 52143
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Huddinge, SE 141 86
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Lund, 22185
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Stockholm, 11522
Australia3 sites
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Elizabeth Vale, South Australia, 5112
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Newcastle, New South Wales, 2292
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Warrawong, New South Wales, 2502
Greece3 sites
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Ampelokipoi, 11527
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Athens, 11521
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Melíssia, 15126
Germany2 sites
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Dresden, 01307
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Schkeuditz, 04435
Netherlands2 sites
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Eindhoven, 5623 EJ
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Maastricht, 6229 HX
Spain2 sites
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Girona, 17007
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Valencia, 46010
Turkey (Türkiye)2 sites
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Ankara, 06100
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Izmir, 35340
Mexico1 site
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Mexico City, 38000
South Korea1 site
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Seoul, 138-736
Switzerland1 site
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Zurich, CH-8091
About this study
Official title: Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Duloxetine, Pregabalin, Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta, LY248686
Administered orally
PregabalinDrug
Administered orally
PlaceboDrug
Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Initial Treatment:
Duloxetine 30 milligram (mg) daily for 1 week
Duloxetine 60 mg daily for 7 weeks
Intensive Treatment:
Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week
Duloxetine 120 mg (60 mg twice daily) daily for 7 weeks Receives: Drug: Duloxetine; Drug: Placebo |
| Pregabalin+Duloxetine | Experimental | Initial Treatment:
Pregabalin 150 mg daily for 1 week
Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks
Intensive Treatment:
Pregabalin 300 mg (150 mg twice daily) daily for 8 weeks
Duloxetine 30 mg daily for 1 week
Duloxetine 60 mg daily for 7 weeks Receives: Drug: Duloxetine; Drug: Pregabalin; Drug: Placebo |
| Pregabalin | Experimental | Initial Treatment:
Pregabalin 150 mg daily for 1 week
Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks
Intensive Treatment:
Pregabalin 450 mg (300 mg in the morning, 150 mg in the evening) daily for 1 week
Pregabalin 600 mg (300 mg twice daily) daily for 7 weeks Receives: Drug: Pregabalin; Drug: Placebo |
| Duloxetine + Pregabalin | Experimental | Initial Treatment:
Duloxetine 30 mg daily for 1 week
Duloxetine 60 mg daily for 7 weeks
Intensive Treatment:
Duloxetine 60 mg daily for 8 weeks
Pregabalin 150 mg daily for 1 week
Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks Receives: Drug: Duloxetine; Drug: Pregabalin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Measured: Week 8, Week 16
Secondary outcomes (14)
Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score
BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Measured: Week 8, Week 16
Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Measured: Week 8 through Week 16
Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Measured: Week 8 through Week 16
Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Measured: Week 8 through Week 16
Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Measured: Week 16
Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Measured: Week 8, Week 16
Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
Measured: Week 8, Week 16
Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Measured: Week 8, Week 16
Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.
Measured: Week 8 through Week 16
Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint
Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Measured: Week 16
Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
Measured: Week 8, Week 16
Mean Change in Heart Rate From Week 8 to Week 16 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
Measured: Week 8, Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint
TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.
Measured: Week 8 through Week 16
Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint
Measured: Week 8 through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionNov 2011
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 Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5AM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089556
- Sponsor's protocol ID
- 13084
- Other IDs
- F1J-EW-HMGQ
- Acronym
- COMBO-DN
- Status last verified
- Jan 2013
- First submitted
- 15 Mar 2010
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"
- ClinicalTrials.gov ID
- NCT01089556
- Acronym / sponsor ID
- COMBO-DN / 13084
- Conditions
- Diabetic Neuropathy, Painful
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 4 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: Duloxetine, Drug: PlaceboInitial Treatment: Duloxetine 30 milligram (mg) daily for 1 week Duloxetine 60 mg daily for 7 weeks Intensive Treatment: Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week Duloxetine 120 mg (60 mg twice daily) daily for 7 weeks |
| Pregabalin+Duloxetine | Experimental | Drug: Duloxetine, Drug: Pregabalin, Drug: PlaceboInitial Treatment: Pregabalin 150 mg daily for 1 week Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks Intensive Treatment: Pregabalin 300 mg (150 mg twice daily) daily for 8 weeks Duloxetine 30 mg daily for 1 week Duloxetine 60 mg daily for 7 weeks |
| Pregabalin | Experimental | Drug: Pregabalin, Drug: PlaceboInitial Treatment: Pregabalin 150 mg daily for 1 week Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks Intensive Treatment: Pregabalin 450 mg (300 mg in the morning, 150 mg in the evening) daily for 1 week Pregabalin 600 mg (300 mg twice daily) daily for 7 weeks |
| Duloxetine + Pregabalin | Experimental | Drug: Duloxetine, Drug: Pregabalin, Drug: PlaceboInitial Treatment: Duloxetine 30 mg daily for 1 week Duloxetine 60 mg daily for 7 weeks Intensive Treatment: Duloxetine 60 mg daily for 8 weeks Pregabalin 150 mg daily for 1 week Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain due to bilateral peripheral neuropathy (caused by type 1 or type 2 diabetes mellitus. Pain must begin in the feet, with relatively symmetrical onset. Daily pain should be present for more than 3 months [assessed by questioning patient]).
- Score of at least 4 on the 24-hour average pain severity score on an 11-point Likert scale [on Brief Pain Inventory (BPI) Modified Short Form] at screening and at randomization.
- Patient is currently not receiving treatment for diabetic peripheral neuropathic pain (DPNP) or was receiving treatment for DPNP, with a drug other than pregabalin or duloxetine, and completed the required washout
- Patient has never received treatment with duloxetine or pregabalin. (However, a short course of less than 15 days of treatment, at any time previously, will be allowed.)
- Stable glycemic control, as assessed by a physician investigator, and hemoglobin A1c (HbA1c) less than or equal to 12% at screening.
Key exclusion criteria (12 listed)
- Have a known hypersensitivity to duloxetine or pregabalin or any of the inactive ingredients or have any contraindication for the use of duloxetine or pregabalin.
- Have uncontrolled narrow-angle glaucoma.
- Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization, or have a potential need to use a MAOI during the study or within 5 days after discontinuation of study drug.
- Have received fluoxetine within 30 days prior to randomization.
- Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
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 |
|---|---|---|
| DuloxetineAlso: Cymbalta, LY248686Administered orally | Drug | Duloxetine, Duloxetine + Pregabalin, Pregabalin+Duloxetine |
| PregabalinAdministered orally | Drug | Duloxetine + Pregabalin, Pregabalin, Pregabalin+Duloxetine |
| PlaceboAdministered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks | Drug | Duloxetine, Duloxetine + Pregabalin, Pregabalin, Pregabalin+Duloxetine |
Primary outcome
Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form
Time frame: Week 8, Week 16
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
14 secondary outcomes
Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score
Time frame: Week 8, Week 16
Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
Time frame: Week 8 through Week 16
Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
Time frame: Week 8 through Week 16
Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
Time frame: Week 8 through Week 16
Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint
Time frame: Week 16
Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
Time frame: Week 8, Week 16
Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)
Time frame: Week 8, Week 16
Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 8, Week 16
Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16
Time frame: Week 8 through Week 16
Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint
Time frame: Week 16
Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint
Time frame: Week 8, Week 16
Mean Change in Heart Rate From Week 8 to Week 16 Endpoint
Time frame: Week 8, Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint
Time frame: Week 8 through Week 16
Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint
Time frame: Week 8 through Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Neuropathy, Painful
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5AM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
54 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine and Pregabalin in people with Diabetic Neuropathy, Painful, run by Eli Lilly and Company at 54 sites in 16 countries.
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 5 inclusion and 12 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in France, Canada, United Kingdom, Croatia, Italy and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Dec 2012). 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 From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form (time frame: Week 8, Week 16). 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 24 Jan 2013.