A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
NCT ID: NCT02411110
Last Updated: 2018-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2015-05-21
2017-01-09
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® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment 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®
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 (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment 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.
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
* Previous treatment with LiRIS®
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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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
IC Study LLC
Escondido, California, United States
Tower Urology
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Genesis Research LLC
San Diego, California, United States
Sutter Health
Vacaville, California, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Manatee Medical Research Institute
Bradenton, Florida, United States
Atlanta Medical Research Instititute
Alpharetta, Georgia, United States
Idaho Urologic Institute
Meridian, Idaho, United States
Associated Surgeons and Physicians LLC DBA Women's Health Advantage
Fort Wayne, Indiana, United States
Regional Urology, LLC
Shreveport, Louisiana, 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
William Beaumont Hospital
Royal Oak, Michigan, United States
Washington University
St Louis, Missouri, United States
Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
St Louis, Missouri, United States
Cooper University Hospita/ Univeristy Urogynecology Associates
Voorhees Township, New Jersey, United States
Western New York Urology Associates
Cheektowaga, New York, United States
BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
Lake Success, New York, United States
Urology Institute of Long Island
Plainview, New York, United States
McKay Urology
Charlotte, North Carolina, United States
Alliance Urology Specialist, P.A.
Greensboro, North Carolina, United States
Eastern Urological Associates, PA
Greenville, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
MetroHealth System
Cleveland, Ohio, United States
Female Sexual and Pelvic Health Institute
Philadelphia, Pennsylvania, United States
Integrity Medical Research (Urology Northwest)
Mountlake Terrace, Washington, United States
University of Washington
Seattle, Washington, United States
Silverado Research Inc
Victoria, British Columbia, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, 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.
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, plesase contact [email protected] for assistance.
Other Identifiers
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201025-002
Identifier Type: -
Identifier Source: org_study_id
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