At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 300 mgfrom 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 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 18, 2011·Updated Jan 28, 2021
In Brief
A Phase 3 clinical trial evaluating Pregabalin and placebo for Diabetic Peripheral Neuropathy. Completed, enrolled 217 participants across 45 sites in 4 countries.
Detailed Summary
The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesCzechia, South Africa, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedNov 2011
Primary CompletionJul 2013
TodayJul 2026
First PostedNov 18, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.6 years ago
Interventions
Pregabalindrug
150-300 mg/day given in 3 divided doses as capsules
placeboother
matching placebo capsules given in 3 divided doses