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

Primary Purpose

Postherpetic Neuralgia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebo
Pregabalin SR tablet 165mg/day
Pregabalin SR tablet 330mg/day
Pregabalin SR tablet 660mg/day
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Pregabalin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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;
  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.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Beijing Chao-yang HospitalRecruiting
  • Beijing Friendship Hospital ,Capital Medical UniversityRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • Sun Yat-Sen Memory Hospital , Sun Yat-Sen UniversityRecruiting
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • The Affiliated Hospital of Hainan Medical CollegeRecruiting
  • Fourth Hospital Of Hebei Medical UniversityRecruiting
  • The Second Hospital Of Hebei Medical UniversityRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Yancheng City NO.1 People's HospitalRecruiting
  • The Affiliated Hospital of Jilin UniversityRecruiting
  • Shengjing Hospital Of China Medical UniversityRecruiting
  • The People's Hospital of Liaoning ProvinceRecruiting
  • Qingdao Municipal Hospital(Group)Recruiting
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • First Hospital Of Shanxi Medical UniversityRecruiting
  • Second Hospital Of Shanxi Medical UniversityRecruiting
  • Xijing Hospital; the Fourth Military Medical UniversityRecruiting
  • People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
  • Xinjiang Uygur Autonomous Region Hospital OF TCMRecruiting
  • First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Hangzhou First People's HospitalRecruiting
  • The First Affiliated Hospital , Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Pregabalin SR tablet 165mg/day

Pregabalin SR tablet 330mg/day

Pregabalin SR tablet 660mg/day

Arm Description

placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)

1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)

1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)

2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)

Outcomes

Primary Outcome Measures

Number of Responders
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint

Secondary Outcome Measures

50% reduction in weekly mean pain score from baseline to study completion
Change of Mean Pain Scores from study completion to baseline
Change of Mean Sleep Interference Scores from study completion to baseline

Full Information

First Posted
July 8, 2015
Last Updated
August 11, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02868801
Brief Title
Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
Acronym
EASOPSRTFP
Official Title
Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Arm Title
Pregabalin SR tablet 165mg/day
Arm Type
Experimental
Arm Description
1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Arm Title
Pregabalin SR tablet 330mg/day
Arm Type
Experimental
Arm Description
1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Arm Title
Pregabalin SR tablet 660mg/day
Arm Type
Experimental
Arm Description
2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablet of pregabalin sustained release tablet
Intervention Description
same intervention as the experimental group
Intervention Type
Drug
Intervention Name(s)
Pregabalin SR tablet 165mg/day
Other Intervention Name(s)
Pregabalin sustained release tablet
Intervention Description
According to the efficacy and safety in titration
Intervention Type
Drug
Intervention Name(s)
Pregabalin SR tablet 330mg/day
Other Intervention Name(s)
Pregabalin sustained release tablet
Intervention Description
According to the efficacy and safety in titration
Intervention Type
Drug
Intervention Name(s)
Pregabalin SR tablet 660mg/day
Other Intervention Name(s)
Pregabalin sustained release tablet
Intervention Description
According to the efficacy and safety in titration.
Primary Outcome Measure Information:
Title
Number of Responders
Description
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
50% reduction in weekly mean pain score from baseline to study completion
Time Frame
15 weeks
Title
Change of Mean Pain Scores from study completion to baseline
Time Frame
15 weeks
Title
Change of Mean Sleep Interference Scores from study completion to baseline
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatient ,Patients can not stay in the hospital overnight; Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash; 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; 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; 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: 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); Patients who had failed to respond to previous treatment for PHN with gabapentin at doses ≥1200 mg/day ; History of using pregabalin or participation in a previous trial of pregabalin; Patients with a skin condition or severe non-PHN pain that might impair the self assessment of pain caused by PHN; Patients with other Nervous system disorders which might impair completing the pain diaries or sleep interference diaries; History of epilepsy and being treated by drug therapy; Previous surgical therapy for PHN; History of using effective therapies during 2 weeks before screening (V0),eg: acupuncture and moxibustion, Transcutaneous Electrical Nerve Stimulation; Potentially retinal toxicity of drugs past or now; Prohibited medications without appropriate washout; Malignancy within the past 2 years; Laboratory examination: WBC<2.5×109/L;ANC<1.5×109/L;PLT<100×109/L;ALT/AST>3ULN; Creatinine clearance ≤ 60 mL/min; Positive antibody of Hepatitis c,Human immunodeficiency virus ,Treponema pallidum ; Patients who are allergic to or intolerant of pregabalin or other drugs which have a similarly chemical structure ; History of illicit drug or alcohol abuse within the last 2 years; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Yunsheng, M.D.
Phone
UN
Email
liangyunsheng@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Qianjin, M.D.
Phone
13787097676
Email
qianlu5860@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Qianjin, M.D.
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital ,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen Memory Hospital , Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Hainan Medical College
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Name
Fourth Hospital Of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital Of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Yancheng City NO.1 People's Hospital
City
Yancheng
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital Of China Medical University
City
Shengyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
Qingdao Municipal Hospital(Group)
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital Of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Second Hospital Of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Xijing Hospital; the Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Wulumuqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Xinjiang Uygur Autonomous Region Hospital OF TCM
City
Wulumuqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital , Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16466610
Citation
van Seventer R, Feister HA, Young JP Jr, Stoker M, Versavel M, Rigaudy L. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin. 2006 Feb;22(2):375-84. doi: 10.1185/030079906x80404.
Results Reference
result

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Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia

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