CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 enrolled
Drug / intervention
Pregabalin (Lyrica) +3 moredrug
Likely dose
Pregabalin 150 mg/day, 300 mg/day, or 600 mg/day orally in divided dosesAI-extracted
Key inclusion· 2
  • ✓Diagnosis of peripheral neuropathic pain caused by lesion of peripheral nervous system with sensory symptoms and signs, present for at least 6 months at screening
  • ✓Completed at least 4 daily pain diaries at baseline with mean weekly pain score ≥4
Key exclusion· 5
  • ✕Cervical or lumbo-sacral radiculopathy
  • ✕Operated or non-operated chronic low back pain
  • ✕Carpal tunnel syndrome or other entrapment-related neuropathic pain
  • ✕Complex regional pain syndrome (type 1 and 2)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00219544
NCT00219544Phase 3Completed
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A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 22, 2005·Updated Jan 22, 2021

In Brief

A Phase 3 clinical trial evaluating Pregabalin (Lyrica) and Placebo for Neuropathic Pain. Completed, enrolled 158 participants across 30 sites.

Detailed Summary

This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropathic Pain
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartNov 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

Pregabalin (Lyrica)drug

pregabalin 150mg/day (75mg BID)

Pregabalin (Lyrica)drug

pregabalin 300 mg/day (150mg BID)

Pregabalin (Lyrica)drug

pregabalin 600/day (300mg BID)

Placebodrug

Placebo