CompletedPhase 3

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

Japan372 participantsStarted 2006-09

Plain-language summary

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Visual Analogue Scale (VAS) of pain is higher than 40 mm. * Pain is sustained for more than 3 months after healing of herpes zoster skin rash. Exclusion Criteria: * Malignancy within the past 2 years. * Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia. * Creatinine clearance \</= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions). * Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia. * Skin conditions in the affected dermatome that could alter sensation.

What they're measuring

Mean Pain Scores at Endpoint

Timeframe: Week13/discontinuation

Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations

Timeframe: Week13/discontinuation

Number of Responders

Timeframe: Week13/discontinuation

Mean Pain Scores at Week 1

Timeframe: Week 1

Mean Pain Scores at Week 2

Timeframe: Week 2

Mean Pain Scores at Week 3

Timeframe: Week 3

Mean Pain Scores at Week 4

Timeframe: Week4

Mean Pain Scores at Week 5

Timeframe: Week 5

Mean Pain Scores at Week 6

Trial details

NCT IDNCT00394901

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-11

Results submitted2008-11-07

View on ClinicalTrials.gov More Neuralgia, Postherpetic trials