The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
NCT ID: NCT02868814
Last Updated: 2016-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2016-05-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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)
Pregabalin Release Tablets
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)
Pregabalin Release Tablets
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)
Placebo
Interventions
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Pregabalin Release Tablets
Pregabalin Release Tablets
Placebo
Eligibility Criteria
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Inclusion Criteria
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 any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Xiehe Hospital of Beijing
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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HR-PRBL-FM
Identifier Type: -
Identifier Source: org_study_id
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