NCT01475253 - Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis | Biotech Hunter

Enrollment

104

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions

Interstitial Cystitis

Interventions

DRUG

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.

OTHER

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.

PROCEDURE

Sham Cystoscopy Procedure

Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.

Trial Locations (29)

11040

Arthur Smith Institute for Urology, New Hyde Park

14642

University of Rochester, Department of Urology, Rochester

19104

Penn. Presbyterian Medical Center, Philadelphia

27103

Wake Forest University Health Sciences Medical Center, Winston-Salem

27403

Alliance Urology Specialists, Greensboro

29425

Medical University of South Carolina Urology Ambulatory Care, Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

34205

Manatee Medical Research Institute, LLC, Bradenton

37232

Vanderbilt University Medical Center, Nashville

39202

CRC of Jackson and Southeast Urogynecology, Jackson

44109

MetroHealth Medical Center, Cleveland

47130

First Urology, Jeffersonville

48073

William Beaumont Hospital, Royal Oak

49503

Female Pelvic Medicine & Urogynecology, Grand Rapids

71106

Regional Urology LLC, Shreveport

80220

Genitourinary Surgical Consultants, Denver

83642

Idaho Urologic Center, Meridian

83814

North Idaho Urology, Coeur d'Alene

85306

Clinical Trials of Arizona, Glendale

89148

Sheldon Freedman, MD Ltd, Las Vegas

91741

Citrus Valley Medical Research, Inc, Glendora

94306

Stanford University Department of Urology, Stanford

98043

Integrity Medical Research, Mountlake Terrace

06032

Women's Health Specialty Care, Farmington

06052

Grove Hill Clinical Research, New Britain

01805

Lahey Clinic Medical Center, Burlington

02472

Bay State Clinical Trials, Inc, Watertown

V8V 3N1

Pacific Urological Research, Victoria

K7L 3J7

Centre for Applied Urologic Research/Kingston General Hospital, Kingston