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

August 11, 2016 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Chao-Yang Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Friendship Hospital ,Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memory Hospital , Sun Yat-Sen University
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • The Affiliated Hospital of Hainan Medical College
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Fourth Hospital of Hebei Medical University
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital Of Central South University
      • Changsha, Hunan, China
        • Recruiting
        • The third xiangya hospital of Central South University
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
      • Yancheng, Jiangsu, China
        • Recruiting
        • Yancheng City NO.1 People's Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The Affiliated Hospital of Jilin University
    • Liaoning
      • Shengyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China
        • Recruiting
        • The People's Hospital of Liaoning Province
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Qingdao Municipal Hospital（Group）
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • First Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China
        • Recruiting
        • Second Hospital of Shanxi Medical University
      • Xi'an, Shanxi, China
        • Recruiting
        • Xijing Hospital; the Fourth Military Medical University
    • Xinjiang
      • Wulumuqi, Xinjiang, China
        • Recruiting
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Wulumuqi, Xinjiang, China
        • Recruiting
        • Xinjiang Uygur Autonomous Region Hospital OF TCM
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital , Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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；
  11. Malignancy within the past 2 years；
  12. Laboratory examination: WBC<2.5×109/L；ANC<1.5×109/L；PLT<100×109/L；ALT/AST>3ULN；
  13. Creatinine clearance ≤ 60 mL/min；
  14. Positive antibody of Hepatitis c，Human immunodeficiency virus ，Treponema pallidum ；
  15. Patients who are allergic to or intolerant of pregabalin or other drugs which have a similarly chemical structure ；
  16. History of illicit drug or alcohol abuse within the last 2 years；
  17. Clinically significant or unstable hepatic, respiratory, or hematologic illnesses or psychologic conditions; unstable cardiovascular disease which may increase the risk of participation the clinical trial in the opinion of the study investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Drug: Placebo
same intervention as the experimental group
Other Names:
  • Placebo tablet of pregabalin sustained release tablet
Experimental: Pregabalin SR tablet 165mg/day
1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Drug: Pregabalin SR tablet 165mg/day
According to the efficacy and safety in titration
Other Names:
  • Pregabalin sustained release tablet
Experimental: Pregabalin SR tablet 330mg/day
1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Drug: Pregabalin SR tablet 330mg/day
According to the efficacy and safety in titration
Other Names:
  • Pregabalin sustained release tablet
Experimental: Pregabalin SR tablet 660mg/day
2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Drug: Pregabalin SR tablet 660mg/day
According to the efficacy and safety in titration.
Other Names:
  • Pregabalin sustained release tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Responders
Time Frame: 15 weeks
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
15 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
50% reduction in weekly mean pain score from baseline to study completion
Time Frame: 15 weeks
15 weeks
Change of Mean Pain Scores from study completion to baseline
Time Frame: 15 weeks
15 weeks
Change of Mean Sleep Interference Scores from study completion to baseline
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Lu Qianjin, M.D., Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRPRBL-PHN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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