Efficacy and Tolerability of ELMIRON

Condition(s) targeted: Interstitial Cystitis

Intervention: ELMIRON (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting. Expecting to enroll 645 people.

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The purpose of this research study is to test two doses of a drug called ELMIRON (pentosan polysulfate sodium). ELMIRON has been approved by the U. S. FDA for the relief of bladder pain or discomfort associated with interstitial cystitis (IC). You may not be on other medications that could affect your IC symptoms such as antihistamines, antidepressants, anticholinergics, or antispasmodics.

Official title: Multi-Center, Randomized, Double-Blind, PBO-Controlled Parallel Evaluation of the Efficacy and Tolerability of ELMIRON

Study design: Interventional, Treatment

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have experienced bladder pain, urinary urgency, and urinary frequency, each not related to a urinary tract infection, for at least the previous 6 months prior to study entry.

- Participant must have averaged > or equal to 10 voids per day over 3 consecutive days and averaged > or equal to 1 nocturnal void

Exclusion Criteria:

- Participants who are currently (within the last 1 month) receiving other medications that may affect symptoms of IC (i. e. antidepressants, antihistamines, antispasmodics, and anticholinergics.

University of Alabama, Birmingham, Alabama 35294, United States; Recruiting
Study Coordinator, Phone: 205-975-9448

Millenium Therapeutic and Research, Birmingham, Alabama 35205, United States; Recruiting
Study Coordinator, Phone: 205-930-8442

Urology Center of Alabama, PC, Homewood, Alabama 35209, United States; No longer recruiting

Alaska Clinical Research, Anchorage, Alaska 99508, United States; Recruiting
Study Coordinator, Phone: 907-276-1455

Urogynecology Clinic Royal Alexandra Hospital, Edmonton, Alberta T5H3V9, Canada; Recruiting
Study Coordinator, Phone: 780-491-5647

Southern Interior Medical Research Corporation, Kelowna, British Columbia V1Y2H4, Canada; Recruiting
Study Coordinator, RN, Phone: 250-763-3842

Can-Med Clinical Research Inc, Victoria, British Columbia V8R6T9, Canada; Recruiting
Study Coordinator, Phone: 250-370-2606

G.Steinhoff Clinical Research, Victoria, British Columbia V8V3N1, Canada; Recruiting
Study Coordinator, Phone: 250-388-0840

Andreou Research, Surrey, British Columbia V3V1N1, Canada; Recruiting
Study Coordinator, Phone: 604-583-2271

San Bernardino Urological Association, San Bernardino, California 92404, United States; No longer recruiting

Scripps Clinic and Research Institute, LaJolla, California 92037, United States; Recruiting
Study Coordinator, Phone: 858-554-6678

San Diego Uro-Research, San Diego, California 92101, United States; Recruiting
Study Coordinator, Phone: 619-236-0045

Western Clinical Research Inc, Torrance, California 90505, United States; Recruiting
Study Coordinator, Phone: 310-378-5003, Ext: 142

Urogynecology Associates of Colorado, Denver, Colorado 80220, United States; No longer recruiting

Longmont Medical Research Network, Longmont, Colorado 80501, United States; No longer recruiting

Urology Consultants, Longwood, Florida 32750, United States; Recruiting
Study Coordinator, Phone: 407-596-1119

Private Practice, Plantation, Florida 33317, United States; Recruiting
Study Coordinator, Phone: 954-587-7010

Advanced Research Institute, New Port Richey, Florida 34652, United States; Recruiting
Study Coordinator, Phone: 727-842-9561

Cleveland Clinic Florida, Fort Lauderdale, Florida 33331, United States; Recruiting
Study Coordinator, Phone: 954-659-5199

Shepard Center, Atlanta, Georgia 30309, United States; Recruiting
Study Coordinator, Phone: 404-367-1392

Urological Associates, Peoria, Illinois 61614, United States; Recruiting
Study Coordinator, Phone: 309-683-1125

Evanston Continence Center, Evanston, Illinois 60201, United States; Recruiting
Study Coordinator, Phone: 847-570-2750

St. Marys Good Samaritan Hospital, Centralia, Illinois 62801, United States; Recruiting
Study Coordinator, Phone: 618-532-5522

Metropolitan Urology, Jeffersonville, Indiana 47130, United States; Recruiting
Study Coordinator, Phone: 812-288-2611

Wayne State University Urologists, Detroit, Michigan 48201, United States; Recruiting
Study Coordinator, Phone: 313-966-7101

Urological Research Center, St. Louis, Missouri 63141, United States; Recruiting
Study Coordinator, Phone: 314-996-8507

Private Practice, Henderson, Nevada 89014, United States; Recruiting
Study Coordinator, Phone: 702-454-6226

Dr. Allan Patrick Professional Corp, Fredericton, New Brunswick E3B5B8, Canada; Recruiting
Study Coordinator, Phone: 506-444-9020

Associates in Urology, West Orange, New Jersey 07052, United States; Recruiting
Study Coordinator, Phone: 973-325-6100

Upstate Urology, Albany, New York 12206, United States; Terminated

Community Care Physicians, Albany, New York 12208, United States; Recruiting
Study Coordinator, Phone: 518-262-6050

McKay Urology, Charlotte, North Carolina 28204, United States; Recruiting
Study Coordinator, Phone: 704-355-7466

Northeast Urology Research, Concord, North Carolina 28025, United States; Recruiting
Study Coordinator, Phone: 704-467-1286

Women's Health Alliance of the Piedmont, Winston-Salem, North Carolina 27103, United States; Recruiting
Study Coordinator, Phone: 336-765-9350

Urology Inc. Valley Professional Center, Kentville, Nova Scotia B4N4K9, Canada; Recruiting
Study Coordinator, Phone: 902-679-0536

QEII Health Sciences Centre, Halifax, Nova Scotia B3H3A7, Canada; Recruiting
Study Coordinator, Phone: 902-473-2895

OB-GYN Physicians Inc., Lima, Ohio 45805, United States; Recruiting
Study Coordinator, Phone: 419-222-1000

Private Practice, Tulsa, Oklahoma 74104, United States; Recruiting
Study Coordinator, Phone: 918-878-8431

Private Practice, Ponca City, Oklahoma 74601, United States; Recruiting
Study Coordinator, Phone: 580-765-1969

Toronto Urology Study Group/CMX, Toronto, Ontario M6A3B5, Canada; Recruiting
Study Coordinator, Phone: 416-256-2737

Mount Sinai Hospital, Toronto, Ontario M5G1Z5, Canada; Recruiting
Study Coordinator, Phone: 416-586-4617

Probity Medical Research, Kitchener, Ontario N2M5N4, Canada; Recruiting
Study Coordinator, Phone: 519-576-0768

Sunnybrook & Women's College HSC, Toronto, Ontario M4N3M5, Canada; Recruiting
Study Coordinator, Phone: 416-480-6100, Ext: 2309

Mor Urology Inc. Bayview Business Center, Newmarket, Ontario L3X1W1, Canada; Recruiting
Study Coordinator, Phone: 905-836-4696

The Urology Resource Center, Burlington, Ontario L7S1V2, Canada; No longer recruiting

Queen's University, Kingston, Ontario K7L2V7, Canada; Recruiting
Study Coordinator, Phone: 613-549-6666, Ext: 4778

The Royal Court Medical Center, Barrie, Ontario L4M4S5, Canada; Recruiting
Study Coordinator, Phone: 705-727-0551

The Urology Clinic, Portland, Oregon 97214, United States; No longer recruiting

Private Practice, Medford, Oregon 97504, United States; Recruiting
Study Coordinator, Phone: 541-773-5500

Philadelphia Urosurgical Associates, Philadelphia, Pennsylvania 19146, United States; Recruiting
Study Coordinator, Phone: 215-893-6508

Urology Associates, Nashville, Tennessee 37209, United States; No longer recruiting

Research Across America, Dallas, Texas 75234, United States; Recruiting
Study Coordinator, Phone: 972-241-1222

Urology San Antonio PA, San Antonio, Texas 78229, United States; Recruiting
Study Coordinator, Phone: 210-617-4116

Benchmark Research, Austin, Texas 78705, United States; Recruiting
Study Coordinator, Phone: 512-478-5416

Private Practice, Ogden, Utah 84403, United States; Recruiting
Study Coordinator, Phone: 801-525-8837

Middleton Urological Associates, Salt Lake City, Utah 84107, United States; Recruiting
Study Coordinator, Phone: 801-288-0607

Virginia Urology, Richmond, Virginia 23235, United States; Recruiting
Study Coordinator, Phone: 804-288-2785, Ext: 122

Urology Northwest, P.S., Seattle, Washington 98133, United States; Recruiting
Study Coordinator, Phone: 206-985-8080

University of Washington Dept of Urology, Seattle, Washington 98195, United States; Recruiting
Study Coordinator, Phone: 206-616-7416

Starting date: August 2003
Last updated: August 8, 2006