At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 123 enrolled
Drug / intervention
pregabalindrug
Likely dose
pregabalin 600 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.
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 5, 2007·Updated Jan 25, 2021
In Brief
A Phase 3 clinical trial evaluating pregabalin for Diabetic Neuropathy, Painful. Completed, enrolled 123 participants across 27 sites.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartFeb 2008
Primary CompletionJan 2010
TodayJul 2026
First PostedNov 5, 2007
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.7 years ago
Interventions
pregabalindrug
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks