Painful Diabetic Peripheral Neuropathy (PDPN)Phase 3PACENCT01478607
A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients
A Phase 3 study testing QUTENZA in people with Painful Diabetic Peripheral Neuropathy (PDPN), run by Astellas Pharma Inc at 64 sites in 11 countries.
Trial summary
The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy (PDPN)
- What is being tested?
- QUTENZA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 64 sitesin 11 countries
- Study dates
- Nov 2011to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
- Stable glycemic control for at least 6 months prior to screening visit
- Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit
Who cannot join
- Primary pain associated with PDPN in the ankles or above
- Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
- Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
- Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives
Trial locations and contacts
64 sites in 11 countries.
64 sites in 11 countries
Poland11 sites
Site: 965
Bialystok, 15435
Site: 961
Bydgoszcz, 85822
Site: 957
Elblag, 82300
Site: 958
Gdynia, 81049
Site: 954
Katowice, 40954
Site: 964
Krakow, 31530
Site: 951
Lodz, 90153
Site: 966
Lubin, 59300
Site: 953
Poznan, 61655
Site: 959
Torun, 87100
Site: 960
Warsaw, 1868
Ukraine11 sites
Site: 808
Chernihiv, 14034
Site: 803
Kharkiv, 61037
Site: 812
Kvuv, 79010
Site: 805
Kyiv, 2091
Site: 807
Kyiv, 4053
Site: 806
Kyiv, 4114
Site: 810
Lviv, 79010
Site: 802
Mykolayiv, 54003
Site: 801
Odesa, 65009
Site: 813
Vinnitsa, 21010
Site: 815
Zaporizhzhya, 69001
Czechia9 sites
Site: 903
Beroun, 26601
Site: 910
Brno, 60200
Site: 908
Choceň, 56501
Site: 911
Litoměřice, 41201
Site: 906
Ostrava, 71000
Site: 904
Polička, 57201
Site: 901
Prague, 14000
Site: 902
Přerov, 75003
Site: 909
Rychnov nad Kněžnou, 51601
Germany9 sites
Site: 508
Chiemsee, 83209
Site: 509
Cologne, 50937
Site: 502
Dresden, 1307
Site: 501
Falkensee, 14612
Site: 514
Frankfurt, 60311
Site: 507
Hamburg, 22177
Site: 505
Leipzig, 04109
Site: 506
Münster, 48145
Site: 512
Wangen, 88239
Russia9 sites
Site: 714
Kemerovo, 150062
Site: 703
Saint Petersburg, 191015
Site: 716
Saint Petersburg, 194358
Site: 704
Saint Petersburg, 79117120826
Site: 706
Saint Petersburg, 79117778999
Site: 708
Samara, 79117778999
Site: 709
Saratov, 79117120826
Site: 713
Tomsk, 79117778999
Site: 711
Yaroslavl, 79117778999
France4 sites
Site: 207
Bron, 69677
Site: 202
Paris, 75004
Site: 201
Pierre-Bénite, 69495
Site: 206
Toulouse, 31059
United Kingdom4 sites
Site: 102
Chorley, PR7 1PP
Site: 103
Liverpool, L7 8XP
Site: 104
Poole, BH15 2JB
Site: 101
Rugby, CV22 5PX
Spain3 sites
Site: 303
Valencia, 46010
Site: 304
Valencia, 46014
Site: 305
Valladolid, 47012
About this study
Official title: A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy
The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
Read the detailed description
Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.
- Being tested
- QUTENZA
- Keywords
- Painful Diabetic Peripheral Neuropathy, Qutenza
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUTENZADrug
Also called Capsaisin
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
| Study group | Role | What they receive |
|---|---|---|
| 1. Qutenza 30 minutes + SOC | Experimental | Not described Receives: Drug: QUTENZA |
| 2. Qutenza 60 minutes + SOC | Experimental | Not described Receives: Drug: QUTENZA |
| 3. SOC | No intervention | Subjects randomized to this group will receive treatment optimized for them on an individual basis. The investigator will be free to provide whatever pharmacological or other treatment is considered optimal for management of the subject's pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale
Measured: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)
Secondary outcomes (12)
Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing
Physicians measuring neurological function will be blinded to treatment
Measured: Baseline till End of Study (up to 64 weeks)
Tolerability of patch application by dermal assessment
Measured: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)
Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application
Assessed within 15 minutes and 60 minutes after patch removal.
Measured: Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)
Tolerability of patch application by rescue medication use
Measured: Days 1 through 5 after each patch application
Adverse Events and serious adverse Events
Measured: Screening visit through End of study visit (up to 65 weeks)
Vital Signs (heart rate and blood pressure)
In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.
Measured: Screening visit through End of study visit (up to 65 weeks)
Laboratory Analyses
The tests performed at the screening visit will include Hematology: Red Blood Cell Count, White Blood Cell Count, Lymphocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Hemoglobin, Hematocrit and Platelets. Biochemistry: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT), Alkaline Phosphatase, Sodium, Potassium, Blood Urea Nitrogen (BUN), Creatinine and Lipid profile. Subsequent HbA1c and lipid profile follow-up will be done at bi-monthly visits. The other tests will be performed if clinically indicated.
Measured: Screening visit through End of study visit (up to 65 weeks)
Intensity of neuropathic pain using "average pain" NPRS scores
Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)
Measured: Screening visit through End of study visit (up to 65 weeks)
Brief Pain Inventory (BPI) pain severity index and pain interference index
Measured: Screening visit through End of study visit (up to 65 weeks)
Patient Global Impression of Change
Measured: After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)
Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire
Measured: After each patch application, from first patch application through End of Study (up to 64 weeks)
Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit
Measured: End of Study (up to 65 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic Peripheral Neuropathy (PDPN)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Clinical Study Manager, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478607
- Sponsor's protocol ID
- E05-CL-3002
- Other IDs
- 2009-016458-42, 2009
- Acronym
- PACE
- Status last verified
- Oct 2015
- First submitted
- 21 Nov 2011
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251. doi: 10.1186/s12883-016-0752-7.
PubMed 27919222
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01478607
- Acronym / sponsor ID
- PACE / E05-CL-3002
- Keywords
- Painful Diabetic Peripheral Neuropathy, Qutenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
Detailed description
Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Qutenza 30 minutes + SOC | Experimental | Drug: QUTENZA |
| 2. Qutenza 60 minutes + SOC | Experimental | Drug: QUTENZA |
| 3. SOC | No intervention | –Subjects randomized to this group will receive treatment optimized for them on an individual basis. The investigator will be free to provide whatever pharmacological or other treatment is considered optimal for management of the subject's pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
- Stable glycemic control for at least 6 months prior to screening visit
- Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit
Key exclusion criteria (5 listed)
- Primary pain associated with PDPN in the ankles or above
- Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
- Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
- Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives
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 |
|---|---|---|
| QUTENZAAlso: CapsaisinA Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2). | Drug | 1. Qutenza 30 minutes + SOC, 2. Qutenza 60 minutes + SOC |
Primary outcome
Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale
Time frame: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)
12 secondary outcomes
Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing
Time frame: Baseline till End of Study (up to 64 weeks)
Tolerability of patch application by dermal assessment
Time frame: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)
Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application
Time frame: Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)
Tolerability of patch application by rescue medication use
Time frame: Days 1 through 5 after each patch application
Adverse Events and serious adverse Events
Time frame: Screening visit through End of study visit (up to 65 weeks)
Vital Signs (heart rate and blood pressure)
Time frame: Screening visit through End of study visit (up to 65 weeks)
Laboratory Analyses
Time frame: Screening visit through End of study visit (up to 65 weeks)
Intensity of neuropathic pain using "average pain" NPRS scores
Time frame: Screening visit through End of study visit (up to 65 weeks)
Brief Pain Inventory (BPI) pain severity index and pain interference index
Time frame: Screening visit through End of study visit (up to 65 weeks)
Patient Global Impression of Change
Time frame: After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)
Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire
Time frame: After each patch application, from first patch application through End of Study (up to 64 weeks)
Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit
Time frame: End of Study (up to 65 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 27919222Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251. doi: 10.1186/s12883-016-0752-7.
- Link to results on EudraCTLink provided by the sponsor.
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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.
Senior Clinical Study Manager study director
Astellas Pharma Europe B.V.
64 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QUTENZA in people with Painful Diabetic Peripheral Neuropathy (PDPN), run by Astellas Pharma Inc at 64 sites in 11 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 3 inclusion and 5 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Poland, Ukraine, Czechia, Germany, Russia and 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale (time frame: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478607, which also lists 1 linked publication.
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 14 Oct 2015.