Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Neuralgia, Postherpetic

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2007

Estimated Enrollment :

372 Patients enrolled

Trial Details

Trial ID

NCT00394901

Start Date

September 1 2006

End Date

November 1 2007

Last Update

February 9 2021

Active Locations (39)

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Page 1 of 10 (39 locations)

1

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

2

Pfizer Investigational Site

Ichikawa, Chiba, Japan

3

Pfizer Investigational Site

Urayasu, Chiba, Japan

4

Pfizer Investigational Site

Kasuga, Fukuoka, Japan