A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
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
1 other identifier
interventional
59
2 countries
19
Brief Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2015
19 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
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2017
CompletedResults Posted
Study results publicly available
October 5, 2018
CompletedOctober 5, 2018
August 1, 2018
2.2 years
March 17, 2015
June 29, 2018
September 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline in the Number of Hunner's Lesions
Baseline (Day 0) to Week 4
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
Baseline (Day 1) to Week 4
Study Arms (3)
LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)
PLACEBO COMPARATORTreatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
EXPERIMENTALTreatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
EXPERIMENTALTreatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
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 with Hunner's lesions/ulcers
You may not qualify if:
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (19)
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
Sutter Institute for Medical Research
Vacaville, California, 95688, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005, 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
Beaumont Health System
Royal Oak, Michigan, 48073, United States
Washington University School of Medicine Department of Surgery
St Louis, Missouri, 63110, United States
Western New York Urology Associates, LLC
Cheektowaga, New York, 14214, United States
McKay Urology
Charlotte, North Carolina, 28207, United States
Eastern Urological Associates, PA
Greenville, North Carolina, 27834, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103, United States
MetroHealth System/Center for Advanced Gynecology
Cleveland, Ohio, 44109, United States
Philadelphia Urosurgical Associates
Philadelphia, Pennsylvania, 19107, United States
University of Washington
Seattle, Washington, 98195, United States
Aurora Health Care
West Allis, Wisconsin, 53227, United States
Silverado Research Inc
Victoria, British Columbia, V8T 2C1, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
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
March 17, 2015
First Posted
March 20, 2015
Study Start
April 15, 2015
Primary Completion
June 29, 2017
Study Completion
November 20, 2017
Last Updated
October 5, 2018
Results First Posted
October 5, 2018
Record last verified: 2018-08