A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

Completed · Phase 1

Conditions studied: Chronic Interstitial Cystitis

In brief

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.

Key facts

Study ID

NCT01879683

Run by

Allergan

People needed

10

Starts

2013-07-01

Expected to finish

2014-06-01

Last updated by the study team

2015-12-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant women
• History or presence of bladder cancer
• History or presence of any condition that would make it difficult to evaluate bladder symptoms

Where it is running

• Advance Urology Institute — Daytona Beach, Florida, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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