A safety study in which multiple applications of Qutenza combined with standard treatment is compared to standard treatment alone in patient with diabetic nerve pain at the feet.
- Conditions
- Painful Diabetic Peripheral NeuropathyMedDRA version: 14.1Level: LLTClassification code 10012683Term: Diabetic peripheral neuropathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Health Care [N] - Population Characteristics [N01]
- Registration Number
- EUCTR2009-016458-42-IT
- Lead Sponsor
- ASTELLAS PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)