At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 104 enrolled
Drug / intervention
Comparator: pregabalin +1 moredrug
Likely dose
Comparator: 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.
A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug
In Brief
A Phase 1 clinical trial evaluating Comparator: pregabalin and Comparator: Placebo (unspecified) for Neuralgia, Postherpetic and 3 related conditions. Completed, enrolled 104 participants.
Detailed Summary
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedDec 2007
Primary CompletionSep 2008
TodayJul 2026
First PostedDec 10, 2007
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.6 years ago
Interventions
Comparator: pregabalindrug
pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
Comparator: Placebo (unspecified)drug
pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks