Painful Diabetic Peripheral Neuropathy (PDPN) Clinical Trial
— PACEOfficial 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.
| Status | Completed |
| Enrollment | 468 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Site: 601 | Bonheiden | |
| Czech Republic | Site: 903 | Beroun | |
| Czech Republic | Site: 910 | Brno | |
| Czech Republic | Site: 908 | Chocen | |
| Czech Republic | Site: 911 | Litomerice | |
| Czech Republic | Site: 906 | Ostrava | |
| Czech Republic | Site: 904 | Policka | |
| Czech Republic | Site: 901 | Praha 4 | |
| Czech Republic | Site: 902 | Prerov | |
| Czech Republic | Site: 909 | Rychnov nad Kneznou | |
| France | Site: 207 | Bron | |
| France | Site: 202 | Paris | |
| France | Site: 201 | Pierre Benite | |
| France | Site: 206 | Toulouse | |
| Germany | Site: 508 | Chiemsee | |
| Germany | Site: 502 | Dresden | |
| Germany | Site: 501 | Falkensee | |
| Germany | Site: 514 | Frankfurt | |
| Germany | Site: 507 | Hamburg | |
| Germany | Site: 509 | Koln | |
| Germany | Site: 505 | Leipzig | |
| Germany | Site: 506 | Muenster | |
| Germany | Site: 512 | Wangen | |
| Italy | Site: 404 | Milano | |
| Italy | Site: 401 | Roma | |
| Netherlands | Site: 651 | Utrecht | |
| Poland | Site: 965 | Bialystok | |
| Poland | Site: 961 | Bydgoszcz | |
| Poland | Site: 957 | Elblag | |
| Poland | Site: 958 | Gdynia | |
| Poland | Site: 954 | Katowice | |
| Poland | Site: 964 | Krakow | |
| Poland | Site: 951 | Lodz | |
| Poland | Site: 966 | Lubin | |
| Poland | Site: 953 | Poznan | |
| Poland | Site: 959 | Torun | |
| Poland | Site: 960 | Warszawa | |
| Russian Federation | Site: 714 | Kemerovo | |
| Russian Federation | Site: 708 | Samara | |
| Russian Federation | Site: 709 | Saratov | |
| Russian Federation | Site: 703 | St. Petersburg | |
| Russian Federation | Site: 704 | St. Petersburg | |
| Russian Federation | Site: 706 | St. Petersburg | |
| Russian Federation | Site: 716 | St. Petersburg | |
| Russian Federation | Site: 713 | Tomsk | |
| Russian Federation | Site: 711 | Yaroslavl | |
| Spain | Site: 303 | Valencia | |
| Spain | Site: 304 | Valencia | |
| Spain | Site: 305 | Valladolid | |
| Ukraine | Site: 808 | Chernihiv | |
| Ukraine | Site: 803 | Kharkiv | |
| Ukraine | Site: 812 | Kvuv | |
| Ukraine | Site: 805 | Kyiv | |
| Ukraine | Site: 806 | Kyiv | |
| Ukraine | Site: 807 | Kyiv | |
| Ukraine | Site: 810 | Lviv | |
| Ukraine | Site: 802 | Mykolayiv | |
| Ukraine | Site: 801 | Odesa | |
| Ukraine | Site: 813 | Vinnitsa | |
| Ukraine | Site: 815 | Zaporizhzhya | |
| United Kingdom | Site: 102 | Chorley | |
| United Kingdom | Site: 103 | Liverpool | |
| United Kingdom | Site: 104 | Poole | |
| United Kingdom | Site: 101 | Rugby |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Belgium, Czech Republic, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | |
| Secondary | Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing | Physicians measuring neurological function will be blinded to treatment | Baseline till End of Study (up to 64 weeks) | No |
| Secondary | Tolerability of patch application by dermal assessment | Screening till Last visit when QUTENZA patch is applied (up to 53 weeks) | No | |
| Secondary | 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. | Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks) | No |
| Secondary | Tolerability of patch application by rescue medication use | Days 1 through 5 after each patch application | No | |
| Secondary | Adverse Events and serious adverse Events | Screening visit through End of study visit (up to 65 weeks) | Yes | |
| Secondary | 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. | Screening visit through End of study visit (up to 65 weeks) | No |
| Secondary | 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. | Screening visit through End of study visit (up to 65 weeks) | No |
| Secondary | Intensity of neuropathic pain using "average pain" NPRS scores | Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) | Screening visit through End of study visit (up to 65 weeks) | No |
| Secondary | Brief Pain Inventory (BPI) pain severity index and pain interference index | Screening visit through End of study visit (up to 65 weeks) | No | |
| Secondary | Patient Global Impression of Change | After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks) | No | |
| Secondary | 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) | No | |
| Secondary | Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit | End of Study (up to 65 weeks) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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