Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

Study Identifier
TAR-100-103
CT.gov Identifier
NCT01150565
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 low dose and LiRIS high dose
    • Phase
    Phase 1
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Female patients ≥ 18 years of age * If of child-bearing potential, agrees to use effective contraception defined by protocol * Capable of understanding and completing symptom diaries and questionnaires as required in the study * Diagnosed with IC, as defined by protocol criteria
    Exclusion Criteria:
    * Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS * History or presence of any medical condition that would interfere with ability to assess symptoms * Pregnant or lactating patients

    Protocol Summary

    The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

    Study Locations

    Location
    Status
    Location
    Dr. Steinhoff Clinical Research
    Victoria, British Columbia, Canada, V8V 3N1
    Status
    Not applicable
    Location
    Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
    Halifax, Nova Scotia, Canada, B3H 3A7
    Status
    Not applicable
    Location
    Centre for Applied Urological Research
    Kingston, Ontario, Canada, K7L 3J7
    Status
    Not applicable