Clinical trial NCT02411110: A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystitis, Interstitial
Painful Bladder Syndrome
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 131
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/bladder pain syndrome.


Eligibility criteria: 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®

Primary outcomes:
measure: Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
timeFrame: Baseline (Days -7 to 0) to Treatment 1 Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Escondido
country: United States
facility: IC Study LLC
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: Vacaville
country: United States
facility: Sutter Health
state: California
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Medical Research Institute
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Instititute
state: Georgia
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Fort Wayne
country: United States
facility: Associated Surgeons and Physicians LLC DBA Women's Health Advantage
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
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: William Beaumont Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
state: Missouri
city: Voorhees
country: United States
facility: Cooper University Hospita/ Univeristy Urogynecology Associates
state: New Jersey
city: Cheektowaga
country: United States
facility: Western New York Urology Associates
state: New York
city: Lake Success
country: United States
facility: BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
state: New York
city: Plainview
country: United States
facility: Urology Institute of Long Island
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialist, P.A.
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 University
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Philadelphia
country: United States
facility: Female Sexual and Pelvic Health Institute
state: Pennsylvania
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research (Urology Northwest)
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Victoria
country: Canada
facility: Silverado Research Inc
state: British Columbia
city: Kitchener
country: Canada
facility: Urology Associates/Urologic Medical Research
state: Ontario
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.