Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
NCT ID: NCT02868801
Last Updated: 2016-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2015-03-31
2017-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Placebo
same intervention as the experimental group
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)
Pregabalin SR tablet 165mg/day
According to the efficacy and safety in titration
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)
Pregabalin SR tablet 330mg/day
According to the efficacy and safety in titration
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)
Pregabalin SR tablet 660mg/day
According to the efficacy and safety in titration.
Interventions
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Placebo
same intervention as the experimental group
Pregabalin SR tablet 165mg/day
According to the efficacy and safety in titration
Pregabalin SR tablet 330mg/day
According to the efficacy and safety in titration
Pregabalin SR tablet 660mg/day
According to the efficacy and safety in titration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lu Qianjin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Second Xiangya Hospital of Central South University
Locations
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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, 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
Countries
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Central Contacts
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References
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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.
Other Identifiers
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HRPRBL-PHN
Identifier Type: -
Identifier Source: org_study_id
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