CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 241 enrolled
Drug / intervention
pregabalin +1 moredrug
Likely dose
Pregabalin 150-600 mg/day administered twice daily with flexible, optimized dose scheduleAI-extracted
Key inclusion· 2
  • ✓Confirmed diagnosis of peripheral neuropathic pain syndrome: diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical)
  • ✓Average pain score ≥4 on a 10-point scale over 7 days prior to randomization (Visit 2), with at least 4 daily pain diary entries completed
Key exclusion· 3
  • ✕Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain that may confound assessment of neuropathic pain
  • ✕Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain that may confound assessment or self-evaluation
  • ✕Creatinine clearance <30 mL/min (estimated using Cockcroft and Gault equation)

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

Search/NCT00141219
NCT00141219Phase 3Completed
CompareCT.gov

A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 1, 2005·Updated Feb 9, 2021

In Brief

A Phase 3 clinical trial evaluating pregabalin and Placebo for Diabetic Neuropathies and Neuralgia. Completed, enrolled 241 participants across 10 sites.

Detailed Summary

To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathies, Neuralgia
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.8 years ago

Interventions

pregabalindrug

150-600mg/day, BID

Placebodrug

Placebo