A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

Phase 2

Completed

Conditions: Cystitis, Interstitial
Ulcer

Interventions: Drug: LiRIS®
Drug: LiRIS Placebo

Registration Number: NCT02395042

Lead Sponsor: Allergan

Brief Summary: This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 59

Inclusion Criteria

Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

Exclusion Criteria

Previous treatment with LiRIS®
Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)	LiRIS®	Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS®	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)	LiRIS Placebo	Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)	LiRIS®	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)	LiRIS Placebo	Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)	Baseline (Day -7 to Day 0) to Week 4	The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Hunner's Lesions	Baseline (Day 0) to Week 4	During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions	Baseline (Day 1) to Week 4	A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.

Trial Locations

Locations (19): Anne Arundel Urology, P.A.
🇺🇸
Annapolis, Maryland, United States
Western New York Urology Associates, LLC
🇺🇸
Cheektowaga, New York, United States
Beaumont Health System
🇺🇸
Royal Oak, Michigan, United States
Eastern Urological Associates, PA
🇺🇸
Greenville, North Carolina, United States
Aurora Health Care
🇺🇸
West Allis, Wisconsin, United States
Sunnybrook Health Science Centre
🇨🇦
Toronto, Ontario, Canada
Silverado Research Inc
🇨🇦
Victoria, British Columbia, Canada
Sutter Institute for Medical Research
🇺🇸
Vacaville, California, United States
Tri Valley Urology Medical Group
🇺🇸
Murrieta, California, United States
Women's Health Specialty Care
🇺🇸
Farmington, Connecticut, United States
Chesapeake Urology Research Associates
🇺🇸
Baltimore, Maryland, United States
McKay Urology
🇺🇸
Charlotte, North Carolina, United States
Atlanta Medical Research Institute
🇺🇸
Alpharetta, Georgia, United States
Washington University School of Medicine Department of Surgery
🇺🇸
Saint Louis, Missouri, United States
Beyer Research
🇺🇸
Kalamazoo, Michigan, United States
MetroHealth System/Center for Advanced Gynecology
🇺🇸
Cleveland, Ohio, United States
Wake Forest Baptist Health
🇺🇸
Winston-Salem, North Carolina, United States
Philadelphia Urosurgical Associates
🇺🇸
Philadelphia, Pennsylvania, United States
University of Washington
🇺🇸
Seattle, Washington, United States