Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia

Postherpetic Neuralgia Clinical Trial

— EASOPSRTFP  

Official title:

Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02868801
• Other study ID #: HRPRBL-PHN
• Status: Recruiting
• Phase: Phase 3
• First received: July 8, 2015
• Last updated: August 11, 2016
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: February 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Liang Yunsheng, M.D.
• Phone: UN
• Email: liangyunsheng[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.

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 information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• Placebo
same intervention as the experimental group
• Pregabalin SR tablet 165mg/day
According to the efficacy and safety in titration
• Pregabalin SR tablet 330mg/day
According to the efficacy and safety in titration
• Pregabalin SR tablet 660mg/day
According to the efficacy and safety in titration.

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital ,Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	The Affiliated Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sun Yat-Sen Memory Hospital , Sun Yat-Sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Affiliated Hospital of Hainan Medical College	Haikou	Hainan
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital , Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Qingdao Municipal Hospital(Group)	Qingdao	Shandong
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital Of China Medical University	Shengyang	Liaoning
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	Fourth Hospital Of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Hospital Of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	First Hospital Of Shanxi Medical University	Taiyuan	Shanxi
China	Second Hospital Of Shanxi Medical University	Taiyuan	Shanxi
China	People's Hospital of Xinjiang Uygur Autonomous Region	Wulumuqi	Xinjiang
China	Xinjiang Uygur Autonomous Region Hospital OF TCM	Wulumuqi	Xinjiang
China	Xijing Hospital; the Fourth Military Medical University	Xi'an	Shanxi
China	Yancheng City NO.1 People's Hospital	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	50% reduction in weekly mean pain score from baseline to study completion		15 weeks	No
Secondary	Change of Mean Pain Scores from study completion to baseline		15 weeks	No
Secondary	Change of Mean Sleep Interference Scores from study completion to baseline		15 weeks	No