A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

Study Identifier
TAR-100-105
CT.gov Identifier
NCT01879683
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bladder Disorder - Interstitial Cystitis
    • Study Drug
  • LiRIS® 400 mg
    • Phase
    Phase 1
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Women age 18 and older * Interstitial Cystitis with history of Hunner's lesions in the bladder * Moderate to severe bladder discomfort * Confirmation of Hunner's lesions in Bladder * Able to report symptom (pain and voiding frequency) in a diary throughout the study
    Exclusion Criteria:
    * Pregnant women * History or presence of bladder cancer * History or presence of any condition that would make it difficult to evaluate bladder symptoms

    Protocol Summary

    The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.

    Study Locations

    Location
    Status
    Location
    Advance Urology Institute
    Daytona Beach, Florida, United States, 32114
    Status
    Not applicable
    Location
    William Beaumont Hospital
    Royal Oak, Michigan, United States, 48073
    Status
    Not applicable