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Trial record 91 of 425 for:    Pregabalin

Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia (EASOPSRTFP)

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ClinicalTrials.gov Identifier: NCT02868801
Recruitment Status : Unknown
Verified February 2016 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
Number of Responders [ Time Frame: 15 weeks ]
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • 50% reduction in weekly mean pain score from baseline to study completion [ Time Frame: 15 weeks ]
  • Change of Mean Pain Scores from study completion to baseline [ Time Frame: 15 weeks ]
  • Change of Mean Sleep Interference Scores from study completion to baseline [ Time Frame: 15 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
Official Title  ICMJE Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia
Intervention  ICMJE
  • Drug: Placebo
    same intervention as the experimental group
    Other Name: Placebo tablet of pregabalin sustained release tablet
  • Drug: Pregabalin SR tablet 165mg/day
    According to the efficacy and safety in titration
    Other Name: Pregabalin sustained release tablet
  • Drug: Pregabalin SR tablet 330mg/day
    According to the efficacy and safety in titration
    Other Name: Pregabalin sustained release tablet
  • Drug: Pregabalin SR tablet 660mg/day
    According to the efficacy and safety in titration.
    Other Name: Pregabalin sustained release tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
    Intervention: Drug: Placebo
  • Experimental: Pregabalin SR tablet 165mg/day
    1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
    Intervention: Drug: Pregabalin SR tablet 165mg/day
  • Experimental: Pregabalin SR tablet 330mg/day
    1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
    Intervention: Drug: Pregabalin SR tablet 330mg/day
  • Experimental: Pregabalin SR tablet 660mg/day
    2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
    Intervention: Drug: Pregabalin SR tablet 660mg/day
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02868801
Other Study ID Numbers  ICMJE HRPRBL-PHN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lu Qianjin, M.D. Central South University
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP