Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

Study Identifier
203818-503
CT.gov Identifier
NCT00445705
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Fibromyalgia
    • Study Drug
  • placebo
  • AGN 203818
    • Phase
    Phase 2
    Sex
    Female
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of fibromyalgia syndrome * Moderate or severe pain associated with fibromyalgia
    Exclusion Criteria:
    * Any other uncontrolled disease * Pregnant or nursing females

    Protocol Summary

    This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

    Study Locations

    Location
    Status
    Location
    Canton, Ohio, United States
    Status
    Not applicable
    Location
    Geneva, Switzerland
    Status
    Not applicable
    Location
    Stanmore, United Kingdom
    Status
    Not applicable