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

Ulcer Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395042
• Other study ID #: 201025-001
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2015
• Est. completion date: November 20, 2017

Study information

• Verified date: August 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 20, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Ulcer

Intervention

Drug:
• LiRIS®
LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.
• LiRIS Placebo
LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)	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.	Baseline (Day -7 to Day 0) to Week 4
Secondary	Change From Baseline in the Number of Hunner's Lesions	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.	Baseline (Day 0) to Week 4
Secondary	Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions	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.	Baseline (Day 1) to Week 4