Painful Diabetic Peripheral Neuropathy MedDRA version: 16.0 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Qutenza
Product Name: Qutenza
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: CAPSAICIN
CAS Number: 404-86-4
Current Sponsor code: N/A
Other descriptive name: CAPSAICIN
Concentra
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures 2. Male or female >18 years of age 3. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes 4. Stable glycemic control for at least 6 months prior to screening visit 5. Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: 1. Primary pain associated with PDPN in the ankles or above 2. Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN 3. Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain 4. 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. 5. Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, EMLA ingredients or adhesives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of repeat applications of QUTENZA administered over a period of 12 months in subjects with PDPN;Secondary Objective: To assess the efficacy of repeat applications of QUTENZA administered over a period of 12 months in subjects with PDPN;Primary end point(s): Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale from baseline to endpoint (discontinuation or End of Study [EoS] visit).;Timepoint(s) of evaluation of this end point: baseline to endpoint (discontinuation or end of study visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Neurological function as assessed by the UENS and sensory testing • Tolerability of patch application by: - dermal assessment (0–7 point severity score on dermal assessment scale); and - “pain now” NPRS scores after patch application - rescue medication use on days 1 through 5 • Adverse events and serious adverse events (SAEs) • Vital signs (heart rate and blood pressure) associated with patch application • Laboratory analyses • Intensity of neuropathic pain using “average pain” NPRS scores (Question 5 of BPI-DN form) • BPI pain severity index and pain interference index • Patient Global Impression of Change (PGIC) • Generic HRQOL measured by European Quality of Life – 5 Dimensions (EQ- 5D) questionnaire. • Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire;Timepoint(s) of evaluation of this end point: baseline to endpoint (discontinuation or end of study visit) | — |
Countries
Czech Republic, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, Ukraine, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V
Outcome results
None listed