Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
EASOPSRTFP
1 other identifier
interventional
280
1 country
27
Brief Summary
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2015
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 16, 2016
February 1, 2016
2.3 years
July 8, 2015
August 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Responders
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
15 weeks
Secondary Outcomes (3)
50% reduction in weekly mean pain score from baseline to study completion
15 weeks
Change of Mean Pain Scores from study completion to baseline
15 weeks
Change of Mean Sleep Interference Scores from study completion to baseline
15 weeks
Study Arms (4)
Placebo
PLACEBO COMPARATORplacebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Pregabalin SR tablet 165mg/day
EXPERIMENTAL1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Pregabalin SR tablet 330mg/day
EXPERIMENTAL1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Pregabalin SR tablet 660mg/day
EXPERIMENTAL2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Interventions
same intervention as the experimental group
According to the efficacy and safety in titration
According to the efficacy and safety in titration
According to the efficacy and safety in titration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 ；
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Yancheng City NO.1 People's Hospital
Yancheng, Jiangsu, China
The Affiliated Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital Of China Medical University
Shengyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Qingdao Municipal Hospital(Group)
Qingdao, Shandong, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
First Hospital Of Shanxi Medical University
Taiyuan, Shanxi, China
Second Hospital Of Shanxi Medical University
Taiyuan, Shanxi, China
Xijing Hospital; the Fourth Military Medical University
Xi’an, Shanxi, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Xinjiang Uygur Autonomous Region Hospital OF TCM
Ürümqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital , Zhejiang University
Hangzhou, Zhejiang, China
Related Publications (1)
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.
PMID: 16466610RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lu Qianjin, M.D.
Second Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2015
First Posted
August 16, 2016
Study Start
March 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 16, 2016
Record last verified: 2016-02