A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

Painful Bladder Syndrome 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/Bladder Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411110
• Other study ID #: 201025-002
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2015
• Last updated: December 6, 2017
• Start date: May 21, 2015
• Est. completion date: January 9, 2017

Study information

• Verified date: December 2017
• 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/bladder pain syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: January 9, 2017
• Est. primary completion date: October 12, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of interstitial cystitis or bladder pain syndrome

Exclusion Criteria:

• Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

• Previous treatment with LiRIS®

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Painful Bladder Syndrome
• Syndrome

Intervention

Combination Product:
• 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	Urology Associates/Urologic Medical Research	Kitchener	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	Silverado Research Inc	Victoria	British Columbia
United States	Atlanta Medical Research Instititute	Alpharetta	Georgia
United States	Anne Arundel Urology, P.A.	Annapolis	Maryland
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Manatee Medical Research Institute	Bradenton	Florida
United States	McKay Urology	Charlotte	North Carolina
United States	Western New York Urology Associates	Cheektowaga	New York
United States	MetroHealth System	Cleveland	Ohio
United States	IC Study LLC	Escondido	California
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Associated Surgeons and Physicians LLC DBA Women's Health Advantage	Fort Wayne	Indiana
United States	Alliance Urology Specialist, P.A.	Greensboro	North Carolina
United States	Eastern Urological Associates, PA	Greenville	North Carolina
United States	Beyer Research	Kalamazoo	Michigan
United States	BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System	Lake Success	New York
United States	Tower Urology	Los Angeles	California
United States	Idaho Urologic Institute	Meridian	Idaho
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Integrity Medical Research (Urology Northwest)	Mountlake Terrace	Washington
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	Yale University	New Haven	Connecticut
United States	Female Sexual and Pelvic Health Institute	Philadelphia	Pennsylvania
United States	Urology Institute of Long Island	Plainview	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Genesis Research LLC	San Diego	California
United States	University of Washington	Seattle	Washington
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Sutter Health	Vacaville	California
United States	Cooper University Hospita/ Univeristy Urogynecology Associates	Voorhees	New Jersey
United States	Wake Forest University	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 Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up	The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded 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 factors (age group: < 40 years or = 40 years and baseline bladder pain NRS: = 6 or > 6) as factors was used for analysis.	Baseline (Days -7 to 0) to Treatment 1 Week 4

External Links

•   Additional Information
•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, plesase contact IR-CTRegistration@Allergan.com for assistance.