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Trial record 91 of 424 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.

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

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Drug: Placebo Drug: Pregabalin SR tablet 165mg/day Drug: Pregabalin SR tablet 330mg/day Drug: Pregabalin SR tablet 660mg/day Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: Placebo
placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose)
Drug: Placebo
same intervention as the experimental group
Other Name: Placebo tablet of pregabalin sustained release tablet

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)
Drug: Pregabalin SR tablet 165mg/day
According to the efficacy and safety in titration
Other Name: Pregabalin sustained release tablet

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)
Drug: Pregabalin SR tablet 330mg/day
According to the efficacy and safety in titration
Other Name: Pregabalin sustained release tablet

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)
Drug: Pregabalin SR tablet 660mg/day
According to the efficacy and safety in titration.
Other Name: Pregabalin sustained release tablet




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 50% reduction in weekly mean pain score from baseline to study completion [ Time Frame: 15 weeks ]
  2. Change of Mean Pain Scores from study completion to baseline [ Time Frame: 15 weeks ]
  3. Change of Mean Sleep Interference Scores from study completion to baseline [ Time Frame: 15 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868801


Contacts
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Contact: Liang Yunsheng, M.D. UN liangyunsheng@hotmail.com
Contact: Lu Qianjin, M.D. 13787097676 qianlu5860@gmail.com

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Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Lu Qianjin, M.D. Central South University

Publications of Results:
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02868801     History of Changes
Other Study ID Numbers: HRPRBL-PHN
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Pregabalin

Additional relevant MeSH terms:
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Pregabalin
Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs