CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 121 enrolled
Drug / intervention
Pregabalindrug
Likely dose
Pregabalin 75 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.

Search/NCT00407511
NCT00407511Phase 4Completed
CompareCT.gov

A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Dec 5, 2006·Updated Feb 9, 2021

In Brief

A Phase 4 clinical trial evaluating Pregabalin for Diabetic Peripheral Neuropathic Pain (DPN) and 3 related conditions. Completed, enrolled 121 participants across 11 sites in 5 countries.

Detailed Summary

Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathic Pain (DPN), Postherpetic Neuralgia (PHN), HIV-related Neuropathic Pain (HIV), Chemotherapy Induced Neuropathic Pain
CountriesColombia, Ecuador, Mexico, Peru, Venezuela
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2006
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.6 years ago

Interventions

Pregabalindrug

Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).