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

Study Overview
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Brief Summary
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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

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Pregabalin Release Tablets
* Drug: Pregabalin Release Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 330mg/day<br>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<br> <br> |
| Experimental: 495mg/day<br>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<br> <br> |
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |