Clinical trial NCT02868801: Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
Official title: Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postherpetic Neuralgia
Keywords: Pregabalin
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Outpatient ，Patients can not stay in the hospital overnight；
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:

1. 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)；
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.

Primary outcomes:
measure: Number of Responders
timeFrame: 15 weeks
Secondary outcomes:
measure: 50% reduction in weekly mean pain score from baseline to study completion
timeFrame: 15 weeks
measure: Change of Mean Pain Scores from study completion to baseline
timeFrame: 15 weeks
measure: Change of Mean Sleep Interference Scores from study completion to baseline
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital ,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen Memory Hospital , Sun Yat-Sen University
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: The Affiliated Hospital of Hainan Medical College
state: Hainan
city: Shijiazhuang
country: China
facility: Fourth Hospital Of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital Of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng City NO.1 People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The Affiliated Hospital of Jilin University
state: Jilin
city: Shengyang
country: China
facility: Shengjing Hospital Of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Municipal Hospital(Group)
state: Shandong
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital Of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital Of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Xijing Hospital; the Fourth Military Medical University
state: Shanxi
city: Wulumuqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Wulumuqi
country: China
facility: Xinjiang Uygur Autonomous Region Hospital OF TCM
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital , Zhejiang University
state: Zhejiang
Study officials:
affiliation: Central South University
name: Lu Qianjin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.