Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
NCT ID: NCT01824303
Last Updated: 2016-01-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2013-03-31
2014-12-31
Brief Summary
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Detailed Description
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In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LiRIS 400 mg
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.
LiRIS 400 mg
LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
LiRIS Placebo
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.
LiRIS Placebo
LiRIS Placebo contains lactose, inactive substance.
Interventions
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LiRIS 400 mg
LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
LiRIS Placebo
LiRIS Placebo contains lactose, inactive substance.
Eligibility Criteria
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Inclusion Criteria
* Women age 18 and over
* Diagnosed with Interstitial Cystitis as defined by protocol
* Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
* Able to comply with visit schedule and diary completion at home
Open-label Extension:
* Must have completed the blinded study prior to screening for the Open-label extension
Exclusion Criteria
* History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
* Bladder or urethral abnormality that would prevent safe insertion of investigational product
* Requiring medication not allowed per study protocol
18 Years
FEMALE
No
Sponsors
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TARIS Biomedical, Inc.
INDUSTRY
Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Curtis Nickel, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University/Kingston General Hospital/Ontario Canada
Locations
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Citrus Valley Medical Research , Inc.
Glendora, California, United States
Atlantic Urological Associates
Daytona Beach, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
The UrogynecologyCenter, LLC
Overland Park, Kansas, United States
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States
William Beaumont Hospitals
Royal Oak, Michigan, United States
North Shore - Long Island Jewish Heath System - Monter Cancer Center
New Hyde Park, New York, United States
Premier Medical Group of the Hudson Valley PC
Newburgh, New York, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Volunteer Research Group, University of Tennessee Medical Center
Knoxville, Tennessee, United States
Exdeo Clinical Research Inc.
Abbotsford, British Columbia, Canada
Centre for Applied Urological Research
Kingston, Ontario, Canada
Countries
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Other Identifiers
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TAR-100-202
Identifier Type: -
Identifier Source: org_study_id
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