NCT02868801

Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	Placebo	same intervention as the experimental group
DRUG	Pregabalin SR tablet 165mg/day	According to the efficacy and safety in titration
DRUG	Pregabalin SR tablet 330mg/day	According to the efficacy and safety in titration
DRUG	Pregabalin SR tablet 660mg/day	According to the efficacy and safety in titration.

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-08-16
• Last updated: 2016-08-16

Locations

27 sites across 1 country: China