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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

NCT02868801•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Outpatient ，Patients can not stay in the hospital overnight；
•2. Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash；
•3. At least 4 days and at least 8 pain diaries(Pain Numeric Rating Scale) must be completed satisfactorily within the seven days of single-blind, placebo run-in period, and the average pain score must be greater than or equal to 4；
•4. At screening (V0) and enrollment (V1), patients must have a score of greater than or equal to 40 mm on the 100 mm pain visual analog scale；
•5. Women were neither pregnant nor lactating, and those of childbearing age had a confirmed negative serum pregnancy test at baseline and practiced an appropriate method of contraception throughout the study.

Exclusion Criteria

•1. Decrease of ≥30% on their pain VAS or ≥ 4 between any two pain diaries during the placebo run-in period.( in order to remove potential placebo-responders)；
•2. Patients who had failed to respond to previous treatment for PHN with gabapentin at doses ≥1200 mg/day ；
•3. History of using pregabalin or participation in a previous trial of pregabalin；
•4. Patients with a skin condition or severe non-PHN pain that might impair the self assessment of pain caused by PHN；
•5. Patients with other Nervous system disorders which might impair completing the pain diaries or sleep interference diaries；
•6. History of epilepsy and being treated by drug therapy；
•7. Previous surgical therapy for PHN；
•8. History of using effective therapies during 2 weeks before screening (V0),eg: acupuncture and moxibustion, Transcutaneous Electrical Nerve Stimulation；
•9. Potentially retinal toxicity of drugs past or now；
•10. Prohibited medications without appropriate washout；
+7 more criteria

Locations (27)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Chao-yang Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Sun Yat-Sen Memory Hospital , Sun Yat-Sen University

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Affiliated Hospital of Hainan Medical College

Haikou, Hainan, China

Fourth Hospital Of Hebei Medical University

Shijiazhuang, Hebei, China

The Second Hospital Of Hebei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

March 1, 2015

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

August 16, 2016

Enrollment

280

ESTIMATED participants

Conditions

Postherpetic Neuralgia

Interventions

Placebo

DRUG

Pregabalin SR tablet 165mg/day

DRUG

Pregabalin SR tablet 330mg/day

DRUG

Pregabalin SR tablet 660mg/day

DRUG

Contacts

Liang Yunsheng, M.D.

CONTACT

UN liangyunsheng@hotmail.com

Lu Qianjin, M.D.

CONTACT

13787097676 qianlu5860@gmail.com

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia

Inclusion Criteria

Exclusion Criteria

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

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