A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
1 other identifier
interventional
131
2 countries
34
Brief Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedStudy Start
First participant enrolled
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2017
CompletedResults Posted
Study results publicly available
January 4, 2018
CompletedJanuary 4, 2018
December 1, 2017
1.4 years
April 3, 2015
December 6, 2017
December 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
EXPERIMENTALTreatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
OTHERTreatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Diagnosis of interstitial cystitis or bladder pain syndrome
You may not qualify if:
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
- Previous treatment with LiRIS®
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (34)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
IC Study LLC
Escondido, California, 92025, United States
Tower Urology
Los Angeles, California, 90048, United States
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
Genesis Research LLC
San Diego, California, 92123, United States
Sutter Health
Vacaville, California, 95688, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Yale University
New Haven, Connecticut, 06519, United States
Manatee Medical Research Institute
Bradenton, Florida, 34205, United States
Atlanta Medical Research Instititute
Alpharetta, Georgia, 30005, United States
Idaho Urologic Institute
Meridian, Idaho, 83642, United States
Associated Surgeons and Physicians LLC DBA Women's Health Advantage
Fort Wayne, Indiana, 46825, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Anne Arundel Urology, P.A.
Annapolis, Maryland, 21401, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, 21237, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Washington University
St Louis, Missouri, 63110, United States
Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
St Louis, Missouri, 63117, United States
Cooper University Hospita/ Univeristy Urogynecology Associates
Voorhees Township, New Jersey, 08043, United States
Western New York Urology Associates
Cheektowaga, New York, 14225, United States
BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
Lake Success, New York, 11042, United States
Urology Institute of Long Island
Plainview, New York, 11803, United States
McKay Urology
Charlotte, North Carolina, 28207, United States
Alliance Urology Specialist, P.A.
Greensboro, North Carolina, 27403, United States
Eastern Urological Associates, PA
Greenville, North Carolina, 27834, United States
Wake Forest University
Winston-Salem, North Carolina, 27103, United States
MetroHealth System
Cleveland, Ohio, 44109, United States
Female Sexual and Pelvic Health Institute
Philadelphia, Pennsylvania, 19107, United States
Integrity Medical Research (Urology Northwest)
Mountlake Terrace, Washington, 98043, United States
University of Washington
Seattle, Washington, 98195, United States
Silverado Research Inc
Victoria, British Columbia, V8T 2C1, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, N2N 2B9, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
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.
PMID: 34288094DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Till Geib
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2015
First Posted
April 8, 2015
Study Start
May 21, 2015
Primary Completion
October 12, 2016
Study Completion
January 9, 2017
Last Updated
January 4, 2018
Results First Posted
January 4, 2018
Record last verified: 2017-12