A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients
- Registration Number
- NCT01478607
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 468
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. Qutenza 30 minutes + SOC QUTENZA - 2. Qutenza 60 minutes + SOC QUTENZA -
- Primary Outcome Measures
Name Time Method Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)
- Secondary Outcome Measures
Name Time Method Tolerability of patch application by dermal assessment Screening till Last visit when QUTENZA patch is applied (up to 53 weeks) Adverse Events and serious adverse Events Screening visit through End of study visit (up to 65 weeks) Laboratory Analyses Screening visit through End of study visit (up to 65 weeks) 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.
Intensity of neuropathic pain using "average pain" NPRS scores Screening visit through End of study visit (up to 65 weeks) Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)
Brief Pain Inventory (BPI) pain severity index and pain interference index Screening visit through End of study visit (up to 65 weeks) Patient Global Impression of Change 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 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 End of Study (up to 65 weeks) Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing Baseline till End of Study (up to 64 weeks) Physicians measuring neurological function will be blinded to treatment
Tolerability of patch application by rescue medication use Days 1 through 5 after each patch application Vital Signs (heart rate and blood pressure) Screening visit through End of study visit (up to 65 weeks) In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.
Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks) Assessed within 15 minutes and 60 minutes after patch removal.
Trial Locations
- Locations (64)
Site: 806
🇺🇦Kyiv, Ukraine
Site: 802
🇺🇦Mykolayiv, Ukraine
Site: 954
🇵🇱Katowice, Poland
Site: 908
🇨🇿Chocen, Czech Republic
Site: 901
🇨🇿Praha 4, Czech Republic
Site: 904
🇨🇿Policka, Czech Republic
Site: 507
🇩🇪Hamburg, Germany
Site: 102
🇬🇧Chorley, United Kingdom
Site: 202
🇫🇷Paris, France
Site: 601
🇧🇪Bonheiden, Belgium
Site: 910
🇨🇿Brno, Czech Republic
Site: 958
🇵🇱Gdynia, Poland
Site: 810
🇺🇦Lviv, Ukraine
Site: 813
🇺🇦Vinnitsa, Ukraine
Site: 902
🇨🇿Prerov, Czech Republic
Site: 909
🇨🇿Rychnov nad Kneznou, Czech Republic
Site: 651
🇳🇱Utrecht, Netherlands
Site: 953
🇵🇱Poznan, Poland
Site: 201
🇫🇷Pierre Benite, France
Site: 404
🇮🇹Milano, Italy
Site: 505
🇩🇪Leipzig, Germany
Site: 951
🇵🇱Lodz, Poland
Site: 703
🇷🇺St. Petersburg, Russian Federation
Site: 303
🇪🇸Valencia, Spain
Site: 704
🇷🇺St. Petersburg, Russian Federation
Site: 801
🇺🇦Odesa, Ukraine
Site: 104
🇬🇧Poole, United Kingdom
Site: 815
🇺🇦Zaporizhzhya, Ukraine
Site: 103
🇬🇧Liverpool, United Kingdom
Site: 101
🇬🇧Rugby, United Kingdom
Site: 903
🇨🇿Beroun, Czech Republic
Site: 906
🇨🇿Ostrava, Czech Republic
Site: 911
🇨🇿Litomerice, Czech Republic
Site: 508
🇩🇪Chiemsee, Germany
Site: 207
🇫🇷Bron, France
Site: 206
🇫🇷Toulouse, France
Site: 509
🇩🇪Koln, Germany
Site: 514
🇩🇪Frankfurt, Germany
Site: 502
🇩🇪Dresden, Germany
Site: 501
🇩🇪Falkensee, Germany
Site: 512
🇩🇪Wangen, Germany
Site: 506
🇩🇪Muenster, Germany
Site: 401
🇮🇹Roma, Italy
Site: 965
🇵🇱Bialystok, Poland
Site: 957
🇵🇱Elblag, Poland
Site: 961
🇵🇱Bydgoszcz, Poland
Site: 966
🇵🇱Lubin, Poland
Site: 708
🇷🇺Samara, Russian Federation
Site: 709
🇷🇺Saratov, Russian Federation
Site: 714
🇷🇺Kemerovo, Russian Federation
Site: 959
🇵🇱Torun, Poland
Site: 716
🇷🇺St. Petersburg, Russian Federation
Site: 713
🇷🇺Tomsk, Russian Federation
Site: 304
🇪🇸Valencia, Spain
Site: 808
🇺🇦Chernihiv, Ukraine
Site: 711
🇷🇺Yaroslavl, Russian Federation
Site: 706
🇷🇺St. Petersburg, Russian Federation
Site: 803
🇺🇦Kharkiv, Ukraine
Site: 305
🇪🇸Valladolid, Spain
Site: 807
🇺🇦Kyiv, Ukraine
Site: 805
🇺🇦Kyiv, Ukraine
Site: 812
🇺🇦Kvuv, Ukraine
Site: 964
🇵🇱Krakow, Poland
Site: 960
🇵🇱Warszawa, Poland