Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

Study Identifier
TAR-100-202
CT.gov Identifier
NCT01824303
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Bladder Disorder - Interstitial Cystitis
    • Study Drug
  • LiRIS 400 mg
    • Phase
    Phase 2
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion Criteria Blinded study: * Women age 18 and over * Diagnosed with Interstitial Cystitis as defined by protocol * Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary * Able to comply with visit schedule and diary completion at home Open-label Extension: * Must have completed the blinded study prior to screening for the Open-label extension Exclusion Criteria (Blinded and Open-Label Extension): * Pregnant or lactating women * History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms * Bladder or urethral abnormality that would prevent safe insertion of investigational product * Requiring medication not allowed per study protocol

    Protocol Summary

    The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

    Study Locations

    Location
    Status
    Location
    Citrus Valley Medical Research , Inc.
    Glendora, California, United States, 91741
    Status
    Not applicable
    Location
    Atlantic Urological Associates
    Daytona Beach, Florida, United States, 32114
    Status
    Not applicable
    Location
    University of Kansas Medical Center
    Kansas City, Kansas, United States, 66160
    Status
    Not applicable
    Location
    The UrogynecologyCenter, LLC
    Overland Park, Kansas, United States, 66209-2002
    Status
    Not applicable
    Location
    Female Pelvic Medicine & Urogynecology Institute of MI
    Grand Rapids, Michigan, United States, 49503
    Status
    Not applicable
    Location
    William Beaumont Hospitals
    Royal Oak, Michigan, United States, 48073
    Status
    Not applicable
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