At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 369 enrolled
Drug / intervention
Capsaicin 8% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
In Brief
A Phase 3 clinical trial evaluating Capsaicin 8% and Placebo for Diabetic Peripheral Neuropathy and Pain. Completed, enrolled 369 participants across 29 sites.
Detailed Summary
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy, Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionFeb 2014
TodayJul 2026
First PostedFeb 15, 2012
Enrollment StartFeb 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.4 years ago
Interventions
Capsaicin 8%drug
Capsaicin 8% transdermal delivery system
Placebodrug
Placebo Patch