Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
- Conditions
- Postherpetic Neuralgia
- Interventions
- Registration Number
- NCT02868801
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pregabalin SR tablet 165mg/day 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) Placebo Placebo placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose) Pregabalin SR tablet 330mg/day 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 660mg/day 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)
- Primary Outcome Measures
Name Time Method Number of Responders 15 weeks A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
- Secondary Outcome Measures
Name Time Method Change of Mean Sleep Interference Scores from study completion to baseline 15 weeks 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
Trial Locations
- Locations (27)
Second Hospital Of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Xinjiang Uygur Autonomous Region Hospital OF TCM
🇨🇳Wulumuqi, 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
Beijing Friendship Hospital ,Capital Medical University
🇨🇳Beijing, Beijing, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Shengjing Hospital Of China Medical University
🇨🇳Shengyang, Liaoning, China
Sun Yat-Sen Memory Hospital , Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Qingdao Municipal Hospital(Group)
🇨🇳Qingdao, Shandong, China
Xijing Hospital; the Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Wulumuqi, Xinjiang, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Chao-yang Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, Hainan, China
The Second Hospital Of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, 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
Fourth Hospital Of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China
First Hospital Of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China