A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
| Status: | Completed |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | June 2014 |
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis
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.
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.
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
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