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Trial record 38 of 133 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies

The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02868814
Recruitment Status : 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 tablets versus placebo for fibromyalgia

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Pregabalin Release Tablets Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 330mg/day
330 mg QD taken orally,1 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Drug: Pregabalin Release Tablets
Experimental: 495mg/day
495 mg QD taken orally,2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Drug: Pregabalin Release Tablets
Placebo Comparator: Placebo
1 or 2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline in mean pain score diary at Endpoint [ Time Frame: Baseline and 15 weeks ]
    derived from the subject's daily pain


Secondary Outcome Measures :
  1. Change from baseline in FIQ scores at Weeks 15 [ Time Frame: Baseline and Weeks 15 ]
  2. Change from baseline in SF-36 scores at Weeks 15 [ Time Frame: Baseline and Weeks 15 ]
  3. Change from baseline in HADS scores at Weeks 15 [ Time Frame: Baseline and Weeks 15 ]
  4. Change from baseline in MOS-SS scores at Weeks 15 [ Time Frame: Baseline and Weeks 15 ]
  5. Quality of Sleep Score from the Daily Sleep Diary [ Time Frame: up to 15 weeks ]
  6. Mean pain score from the subject's daily pain [ Time Frame: up to 15 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).

Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .

Exclusion Criteria:

  • Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.

Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.


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): NCT02868814


Locations
China, Beijing
Xiehe Hospital of Beijing Recruiting
Beijing, Beijing, China, UN
Contact: Wu Qingjun, M.D.    UN    wuqingjun@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02868814     History of Changes
Other Study ID Numbers: HR-PRBL-FM
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs