Clinical trial NCT02395042: A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystitis, Interstitial
Ulcer
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
timeFrame: Baseline (Day -7 to Day 0) to Week 4
Secondary outcomes:
measure: Change From Baseline in the Number of Hunner's Lesions
timeFrame: Baseline (Day 0) to Week 4
measure: Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
timeFrame: Baseline (Day 1) to Week 4
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Vacaville
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Annapolis
country: United States
facility: Anne Arundel Urology, P.A.
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine Department of Surgery
state: Missouri
city: Cheektowaga
country: United States
facility: Western New York Urology Associates, LLC
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Greenville
country: United States
facility: Eastern Urological Associates, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth System/Center for Advanced Gynecology
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Urosurgical Associates
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: West Allis
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Victoria
country: Canada
facility: Silverado Research Inc
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
Study officials:
affiliation: Allergan
name: Till Geib
role: STUDY_DIRECTOR
References:
citation: Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20.