At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 306 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 Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Oct 20, 2011·Updated Jan 28, 2021
In Brief
A Phase 3 clinical trial evaluating pregabalin and placebo for Painful Diabetic Peripheral Neuropathy. Completed, enrolled 306 participants across 61 sites in 4 countries.
Detailed Summary
This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Peripheral Neuropathy
CountriesCzechia, Italy, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartDec 2011
Primary CompletionNov 2013
Study CompletionDec 2013
TodayJul 2026
First PostedOct 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionNov 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.7 years ago
Interventions
pregabalindrug
150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
placebodrug
matching placebo 3 time a day