A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC)and Hunner's Lesions
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis|
- Change from Baseline in appearance of Hunner's Lesion. [ Time Frame: Study Day 14 or 28 ] [ Designated as safety issue: No ]
- Change from baseline in subject reported IC symptoms (bladder pain, urinary frequency) [ Time Frame: Screen (Day -5 to -1); during treatment (Day 0 - 14) and on designated days during follow up period of 4 weeks after treatment. ] [ Designated as safety issue: No ]Subjects rate symptom of bladder pain for 5 days during screening, daily during treatment (study days 0 to 14), and for 3 days prior to follow up visits at 1,2, and 4 weeks after treatment. Subjects also record each daytime and night time void for 3 days during screening, and for 3 days prior to visits on study days 7 and 14, and the follow up visits at 1,2, and 4 weeks after treatment.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: LiRIS® 400 mg
LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Drug: LiRIS® 400 mg
LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879683
|United States, Florida|
|Advance Urology Institute|
|Daytona Beach, Florida, United States, 32114|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth Peters, MD||William Beaumont Hospitals|