At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 314 enrolled
Drug / intervention
placebo +2 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.
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment 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 placebo and pregabalin for Diabetic Neuropathy, Painful. Completed, enrolled 314 participants across 49 sites.
Detailed Summary
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedNov 2007
Primary CompletionMar 2009
TodayJul 2026
First PostedNov 5, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.7 years ago
Interventions
placebodrug
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
pregabalindrug
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
pregabalindrug
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)