Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain

Study Identifier
203818-008
CT.gov Identifier
NCT00441766
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Irritable Bowel Syndrome (IBS)
    • Study Drug
  • AGN 203818
  • placebo
    • Phase
    Phase 2
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of Irritable Bowel Syndrome * Moderate or severe IBS pain
    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 relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

    Study Locations

    Location
    Status
    Location
    Orange, California, United States
    Status
    Not applicable