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The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 330mg/day | Experimental | 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) |
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| 495mg/day | Experimental | 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) |
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| Placebo | Placebo Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin Release Tablets | Drug |
| ||
| Pregabalin Release Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean pain score diary at Endpoint | derived from the subject's daily pain | Baseline and 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiehe Hospital of Beijing | Recruiting | Beijing | Beijing Municipality | UN | China |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Placebo | Drug |
|
| 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 |
| Mean pain score from the subject's daily pain | up to 15 weeks |
| D009422 |
| Nervous System Diseases |