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.

Phase 1

• Conditions: Painful Diabetic Peripheral Neuropathy; MedDRA version: 16.0 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 100000004852; Therapeutic area: Health Care [N] - Population Characteristics [N01]

• Registration Number: EUCTR2009-016458-42-GB
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-02
• Study Completion: 2014-02-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 468

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

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)