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Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia — EASOPSRTFP  

Postherpetic Neuralgia Clinical Trial

Official title:
Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Summary

The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.

Clinical Trial Description

This is a randomized, double-blind, multicenter, placebo-controlled trial to compare the efficacy and safety of pregabalin SR vs placebo in patients with PHN.

The study is conducting at 27 study centers in China. Patients were randomized to receive pregabalin, starting at 165 mg/day and increasing to a maintenance dose of 330 or 660 mg/day, or placebo.

The study includes a 1-week, single-blind, placebo run-in period; a 2-week dose-escalation/optimization phase; a 12-week, fixed-dose treatment period; and a 1-week taper phase. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02868801
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Liang Yunsheng, M.D.
Phone UN
Email liangyunsheng@hotmail.com
Status Recruiting
Phase Phase 3
Start date March 2015
Completion date June 2017
View Details
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