Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
NCT ID: NCT01475253
Last Updated: 2015-09-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
104 participants
INTERVENTIONAL
2011-11-30
2012-12-31
Brief Summary
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Detailed Description
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All patients who complete part 1 of the study have the option to enter the extension.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lidocaine Releasing Intravesical System
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
Lidocaine Releasing Intravesical System - LiRIS®
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
LiRIS containing inactive substance only
LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
LiRIS Placebo
LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
Cystoscopy Procedure
No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.
Sham Cystoscopy Procedure
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Interventions
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Lidocaine Releasing Intravesical System - LiRIS®
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
LiRIS Placebo
LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
Sham Cystoscopy Procedure
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Interstitial Cystitis as defined by protocol
* Able and willing to complete questionnaires and diary
* Able to comply with visit schedule including Day 14 Removal visit
* Completion of blinded study prior to enrolling in unblinded part of study
Exclusion Criteria
* Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
* History or presence of any condition that would make it difficult to evaluate symptoms
* Did not complete blinded study (unblinded part of study only)
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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Clinical Trials of Arizona
Glendale, Arizona, United States
Citrus Valley Medical Research, Inc
Glendora, California, United States
Stanford University Department of Urology
Stanford, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Grove Hill Clinical Research
New Britain, Connecticut, United States
Manatee Medical Research Institute, LLC
Bradenton, Florida, United States
North Idaho Urology
Coeur d'Alene, Idaho, United States
Idaho Urologic Center
Meridian, Idaho, United States
First Urology
Jeffersonville, Indiana, United States
Regional Urology LLC
Shreveport, Louisiana, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Bay State Clinical Trials, Inc
Watertown, Massachusetts, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
CRC of Jackson and Southeast Urogynecology
Jackson, Mississippi, United States
Sheldon Freedman, MD Ltd
Las Vegas, Nevada, United States
Arthur Smith Institute for Urology
New Hyde Park, New York, United States
University of Rochester, Department of Urology
Rochester, New York, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Penn. Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina Urology Ambulatory Care
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Integrity Medical Research
Mountlake Terrace, Washington, United States
Pacific Urological Research
Victoria, British Columbia, Canada
Centre for Applied Urologic Research/Kingston General Hospital
Kingston, Ontario, Canada
Countries
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Other Identifiers
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TAR-100-201
Identifier Type: -
Identifier Source: org_study_id
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