The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
1 other identifier
interventional
240
1 country
1
Brief Summary
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedAugust 16, 2016
July 1, 2016
3 years
July 29, 2016
August 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean pain score diary at Endpoint
derived from the subject's daily pain
Baseline and 15 weeks
Secondary Outcomes (6)
Change from baseline in FIQ scores at Weeks 15
Baseline and Weeks 15
Change from baseline in SF-36 scores at Weeks 15
Baseline and Weeks 15
Change from baseline in HADS scores at Weeks 15
Baseline and Weeks 15
Change from baseline in MOS-SS scores at Weeks 15
Baseline and Weeks 15
Quality of Sleep Score from the Daily Sleep Diary
up to 15 weeks
- +1 more secondary outcomes
Study Arms (3)
330mg/day
EXPERIMENTAL330 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)
495mg/day
EXPERIMENTAL495 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)
Placebo
PLACEBO COMPARATOR1 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiehe Hospital of Beijing
Beijing, Beijing Municipality, UN, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 16, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
August 16, 2016
Record last verified: 2016-07