At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 633 enrolled
Drug / intervention
pregabalin (Lyrica) +1 moredrug
Likely dose
pregabalin (Lyrica) 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 WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 27, 2010·Updated Jan 20, 2021
In Brief
A Phase 3 clinical trial evaluating pregabalin (Lyrica) and Placebo for Diabetic Neuropathy, Painful. Completed, enrolled 633 participants across 172 sites in 4 countries.
Detailed Summary
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesCanada, Puerto Rico, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartMar 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedJan 27, 2010
Enrollment StartMar 31, 2010
Primary CompletionJan 30, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.4 years ago
Interventions
pregabalin (Lyrica)drug
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
Placebodrug
Placebo is supplied as capsules and given 3 times daily.