Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

Study Identifier
TAR-100-201
CT.gov Identifier
NCT01475253
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
  • Lidocaine Releasing Intravesical System - LiRIS®
    • Phase
    Phase 2
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Women age 18 and over * Diagnosed with Interstitial Cystitis as defined by protocol * Able and willing to complete questionnaires and diary * Able to comply with visit schedule including Day 14 Removal visit * Completion of blinded study prior to enrolling in unblinded part of study
    Exclusion Criteria:
    * Pregnant or lactating women * Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product * History or presence of any condition that would make it difficult to evaluate symptoms * Did not complete blinded study (unblinded part of study only)

    Protocol Summary

    The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

    Study Locations

    Location
    Status
    Location
    Clinical Trials of Arizona
    Glendale, Arizona, United States, 85306
    Status
    Not applicable
    Location
    Citrus Valley Medical Research, Inc
    Glendora, California, United States, 91741
    Status
    Not applicable
    Location
    Stanford University Department of Urology
    Stanford, California, United States, 94306
    Status
    Not applicable
    Location
    Genitourinary Surgical Consultants
    Denver, Colorado, United States, 80220
    Status
    Not applicable
    Location
    Women's Health Specialty Care
    Farmington, Connecticut, United States, 06032
    Status
    Not applicable
    Location
    Grove Hill Clinical Research
    New Britain, Connecticut, United States, 06052
    Status
    Not applicable
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