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Sponsored by: |
Allergan |
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Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00445705 |
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. Acetaminophen 4 mg/day will be used as a rescue medication.
Condition | Intervention | Phase |
---|---|---|
Fibromyalgia |
Drug: placebo Drug: 20 mg AGN203818 Drug: 100 mg AGN203818 Drug: 160 mg AGN203818 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 650 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo BID
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Drug: placebo
placebo capsules BID for up to 12 weeks
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2: Experimental
20 mg BID
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Drug: 20 mg AGN203818
20 mg AGN203818 BID for up to 12 weeks
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3: Experimental
100 mg BID
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Drug: 100 mg AGN203818
100 mg AGN203818 BID for up to 12 weeks
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4: Experimental
160 mg BID
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Drug: 160 mg AGN203818
160 mg AGN203818 BID for up to 12 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 203818-503 |
Study First Received: | March 7, 2007 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00445705 |
Health Authority: | United States: Food and Drug Administration |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Nervous System Diseases |