Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose) |
|
| Pregabalin SR tablet 165mg/day | Experimental | 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 | Experimental | 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 | Experimental | 2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | same intervention as the experimental group |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Yunsheng, M.D. | Contact | UN | liangyunsheng@hotmail.com | |
| Lu Qianjin, M.D. | Contact | 13787097676 | qianlu5860@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Qianjin, M.D. | Second Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16466610 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pregabalin SR tablet 165mg/day | Drug | According to the efficacy and safety in titration |
|
|
| Pregabalin SR tablet 330mg/day | Drug | According to the efficacy and safety in titration |
|
|
| Pregabalin SR tablet 660mg/day | Drug | According to the efficacy and safety in titration. |
|
|
| 15 weeks |
| Beijing Chao-yang Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Friendship Hospital ,Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | China |
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
| Sun Yat-Sen Memory Hospital , Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | China |
| The Affiliated Hospital of Hainan Medical College | Recruiting | Haikou | Hainan | China |
| Fourth Hospital Of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
| The Second Hospital Of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
| Yancheng City NO.1 People's Hospital | Recruiting | Yancheng | Jiangsu | China |
| The Affiliated Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
| Shengjing Hospital Of China Medical University | Recruiting | Shengyang | Liaoning | China |
| The People's Hospital of Liaoning Province | Recruiting | Shenyang | Liaoning | China |
| Qingdao Municipal Hospital(Group) | Recruiting | Qingdao | Shandong | China |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
| First Hospital Of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | China |
| Second Hospital Of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | China |
| Xijing Hospital; the Fourth Military Medical University | Recruiting | Xi’an | Shanxi | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Recruiting | Ürümqi | Xinjiang | China |
| Xinjiang Uygur Autonomous Region Hospital OF TCM | Recruiting | Ürümqi | Xinjiang | China |
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital , Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided