Try our beta test site
Trial record 35 of 104 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02868814
First received: July 29, 2016
Last updated: August 11, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia

Condition Intervention Phase
Fibromyalgia
Drug: Pregabalin Release Tablets
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

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

Estimated Enrollment: 240
Study Start Date: May 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02868814     History of Changes
Other Study ID Numbers: HR-PRBL-FM
Study First Received: July 29, 2016
Last Updated: August 11, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on March 24, 2017