A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
NCT ID: NCT02395042
Last Updated: 2018-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2015-04-15
2017-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)
Treatment 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® 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®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Treatment 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®
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
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Treatment 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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
18 Years
FEMALE
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Till Geib
Role: STUDY_DIRECTOR
Allergan
Locations
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Tri Valley Urology Medical Group
Murrieta, California, United States
Sutter Institute for Medical Research
Vacaville, California, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, United States
Anne Arundel Urology, P.A.
Annapolis, Maryland, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Beyer Research
Kalamazoo, Michigan, United States
Beaumont Health System
Royal Oak, Michigan, United States
Washington University School of Medicine Department of Surgery
St Louis, Missouri, United States
Western New York Urology Associates, LLC
Cheektowaga, New York, United States
McKay Urology
Charlotte, North Carolina, United States
Eastern Urological Associates, PA
Greenville, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
MetroHealth System/Center for Advanced Gynecology
Cleveland, Ohio, United States
Philadelphia Urosurgical Associates
Philadelphia, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Aurora Health Care
West Allis, Wisconsin, United States
Silverado Research Inc
Victoria, British Columbia, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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201025-001
Identifier Type: -
Identifier Source: org_study_id
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