Completed
PHASE4
INTERVENTIONAL
NCT00407511
Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
Interventions
Name:
Pregabalin
Type:
DRUG
Description:
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).
Primary Outcomes
Measure:
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
TimeFrame:
Baseline, End of Treatment
Description:
11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.
Trial Information
NCT ID
NCT00407511
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last Updated
December 15, 2025