Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

626

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

April 30, 2014

Study Completion Date

June 30, 2014

Conditions
Diabetic Neuropathy, Painful
Interventions
DRUG

Pregabalin

"Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.~At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day."

DRUG

Placebo matched with pregabalin

Subject will take placebo matched with pregabalin twice a day.

Trial Locations (30)

100050

Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department, Beijing

100191

Peking University Third Hospital, Beijing

100700

Endocrinology Department, Beijing

100730

Beijing Hospital of the Ministry of Health, Beijing

Tongren Hospital Affiliated to Capital Medical University, Beijing

100853

Chinese PLA General Hospital, Beijing

110004

Shengjing hospital of china medical university, Shenyang

130041

Dept. of Endocrinology, The second hospital of Jilin University, Changchun

150001

Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University, Harbin

150086

Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University, Harbin

200003

Shanghai Changzheng Hospital, Shanghai

200040

Huashan Hospital Affiliated Fudan University, Neurology Department, Shanghai

200072

Shanghai Tenth People's Hospital/The Endocrinology Department, Shanghai

200080

Shanghai First People's Hospital, Shanghai

200127

Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department, Shanghai

210029

Jiangsu Province Hospital, Nanjing

250012

Qilu Hospital of Shandong University/department of internal neurology, Jinan

Qilu Hospital of Shandong University, Jinan

300052

Tianjin Medical University General Hospital, Tianjin

310009

The Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou

310016

Sir Run Run Shaw Hospital, School of medicine, Zhejiang University, Hangzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350025

Fuzhou General Hospital of Nanjing Military Command, Fuzhou

400038

Southwest hospital of the third military medical university/Department of Neurology, Chongqing

410008

Xiangya Hospital of Centre-south University, Changsha

430030

Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology, Wuhan

510120

Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou

510180

GuangZhou First Municipal People's Hospital, Guangzhou

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

510515

Nanfang Hospital, Southern Medical University, Guangzhou

All Listed Sponsors
lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

NCT01332149 - Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy | Biotech Hunter | Biotech Hunter