Status:
COMPLETED
A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
Lead Sponsor:
Allergan
Collaborating Sponsors:
TARIS Biomedical, Inc.
Conditions:
Chronic Interstitial Cystitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Pregnant women
- History or presence of bladder cancer
- History or presence of any condition that would make it difficult to evaluate bladder symptoms
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01879683
Start Date
July 1 2013
End Date
June 1 2014
Last Update
December 18 2015
Active Locations (2)
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1
Advance Urology Institute
Daytona Beach, Florida, United States, 32114
2
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073