Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis



Status:Terminated
Conditions:Other Indications, Urology
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2011
End Date:December 2012

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A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension

The purpose of this study is to determine if LiRIS®, an investigational drug-delivery
system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is
inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is
removed via cystoscopy.

The study is conducted in 2 parts - a randomized, blinded part in which patients are
randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo
(LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor
LiRIS Placebo), followed by an open extension part in which all patients are assigned to
receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a
double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the
Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to
Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Inclusion Criteria:

- Women age 18 and over

- 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:

- Pregnant or lactating women

- 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)
We found this trial at
28
sites
Glendale, Arizona 85306
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Lake Street
New Britain, Connecticut 06052
(860) 801-6543
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New Britain, CT
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Bradenton, Florida 34205
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Bradenton, FL
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Burlington, Massachusetts 01805
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Burlington, MA
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Charleston, SC
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Coeur d'Alene, Idaho 83814
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Coeur d'Alene, ID
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Denver, Colorado 80220
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Farmington, Connecticut 06032
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Glendora, California 91741
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Greensboro, North Carolina
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Greensboro, NC
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Jackson, Mississippi 39202
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Jackson, MS
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Jeffersonville, Indiana 47130
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Jeffersonville, IN
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Las Vegas, Nevada 89109
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Las Vegas, NV
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Meridian, Idaho 83642
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Meridian, ID
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Mountlake Terrace, Washington 98043
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Mountlake Terrace, WA
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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New Hyde Park, New York 11040
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Rochester, NY
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Royal Oak, Michigan 48073
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Shreveport, Louisiana 71106
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Stanford, California 94306
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Victoria, British Columbia
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Victoria,
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Watertown, Massachusetts 02472
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Winston-Salem, North Carolina 27103
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