Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia (EASOPSRTFP)
Postherpetic Neuralgia
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Pregabalin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- Beijing Chao-yang HospitalRecruiting
- Beijing Friendship Hospital ,Capital Medical UniversityRecruiting
- China-Japan Friendship HospitalRecruiting
- Fujian Medical University Union HospitalRecruiting
- Sun Yat-Sen Memory Hospital , Sun Yat-Sen UniversityRecruiting
- The Affiliated Hospital of Guizhou Medical UniversityRecruiting
- The Affiliated Hospital of Hainan Medical CollegeRecruiting
- Fourth Hospital Of Hebei Medical UniversityRecruiting
- The Second Hospital Of Hebei Medical UniversityRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- The Third Xiangya Hospital of Central South UniversityRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- Yancheng City NO.1 People's HospitalRecruiting
- The Affiliated Hospital of Jilin UniversityRecruiting
- Shengjing Hospital Of China Medical UniversityRecruiting
- The People's Hospital of Liaoning ProvinceRecruiting
- Qingdao Municipal Hospital(Group)Recruiting
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
- First Hospital Of Shanxi Medical UniversityRecruiting
- Second Hospital Of Shanxi Medical UniversityRecruiting
- Xijing Hospital; the Fourth Military Medical UniversityRecruiting
- People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
- Xinjiang Uygur Autonomous Region Hospital OF TCMRecruiting
- First Affiliated Hospital of Kunming Medical UniversityRecruiting
- Hangzhou First People's HospitalRecruiting
- The First Affiliated Hospital , Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
Pregabalin SR tablet 165mg/day
Pregabalin SR tablet 330mg/day
Pregabalin SR tablet 660mg/day
placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)