An Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis.

Condition(s) targeted: Interstitial Cystitis

Intervention: pentosan polysulfate sodium (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Official(s) and/or principal investigator(s):
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of Elmiron for the Treatment of Interstitial Cystitis

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy parameter is the proportion of patients with at least a 30% reduction in the patient-completed O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) from baseline to Week 24 or last visit

Secondary outcome: Proportion of patients with at least a 4-point reduction in ICSI from baseline to Week 24 or last visit; proportion of patients with >= 50% improvement in Patient Overall Rating of Improvement of Symptoms (PORIS) from baseline to Week 24 or last visit

Detailed description: The purpose of this multi-center, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and 100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis. The hypothesis of the study is that there is no treatment difference in the proportion of responders at study endpoint (Week 24). Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) total score. Safety assessments include vitals signs, laboratory tests, adverse events and physical exams. Patients will receive one of the following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100

mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one

matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg

capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the

morning, afternoon and evening; placebo group - one placebo capsule in the morning,

afternoon and evening

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis

Symptom Index (ICSI) and a score of > 0 on each of the 4 questions on the ICSI

- must have experienced bladder pain, urinary urgency and urinary frequency, each not

related to a urinary tract infection, for at least 6 months prior to entry into the study

- must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) and

averaged >= 1 void at night

- urine culture showing no evidence of urinary tract infection

- urine cytology showing no evidence of neoplastic cells.

Exclusion Criteria:

- Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl

sulfoxide) during or within 4 weeks prior to the study

- patients who have had cytoscopic evaluation within 4 weeks prior to the study

- patients who are currently (within last month) receiving other medications that may

affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines, antispasmodics, anticholinergics)

- patients who are chronic users of Schedule II narcotics or who are using any

scheduled narcotics at the time of study entry

- patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as

tissue plasminogen activator and streptokinase

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Birmingham, Alabama, United States; Recruiting

Homewood, Alabama, United States; Active, not recruiting

Anchorage, Alaska, United States; Recruiting

Edmonton, Alberta, Canada; Active, not recruiting

Victoria, British Columbia, Canada; Active, not recruiting

Surrey, British Columbia, Canada; Recruiting

Kelowna, British Columbia, Canada; Active, not recruiting

La Jolla, California, United States; Recruiting

Torrance, California, United States; Recruiting

San Diego, California, United States; Recruiting

San Carlos, California, United States; Active, not recruiting

San Bernardino, California, United States; Active, not recruiting

Denver, Colorado, United States; Active, not recruiting

Wheat Ridge, Colorado, United States; Active, not recruiting

Longmont, Colorado, United States; Active, not recruiting

Norwalk, Connecticut, United States; Active, not recruiting

Newington, Connecticut, United States; Active, not recruiting

Plantation, Florida, United States; Active, not recruiting

Weston, Florida, United States; Active, not recruiting

Longwood, Florida, United States; Recruiting

New Port Richey, Florida, United States; Recruiting

Atlanta, Georgia, United States; Active, not recruiting

Peoria, Illinois, United States; Active, not recruiting

Centralia, Illinois, United States; Active, not recruiting

Evanston, Illinois, United States; Active, not recruiting

Jeffersonville, Indiana, United States; Active, not recruiting

Detroit, Michigan, United States; Recruiting

Saint Louis, Missouri, United States; Active, not recruiting

Henderson, Nevada, United States; Active, not recruiting

Fredericton, New Brunswick, Canada; Active, not recruiting

West Orange, New Jersey, United States; Active, not recruiting

Albany, New York, United States; Active, not recruiting

Concord, North Carolina, United States; Active, not recruiting

Winston Salem, North Carolina, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Halifax, Nova Scotia, Canada; Active, not recruiting

Kentville, Nova Scotia, Canada; Active, not recruiting

Lima, Ohio, United States; Active, not recruiting

Ponca City, Oklahoma, United States; Recruiting

Tulsa, Oklahoma, United States; Recruiting

Toronto, Ontario, Canada; Active, not recruiting

Newmarket, Ontario, Canada; Recruiting

Barrie, Ontario, Canada; Active, not recruiting

Kingston, Ontario, Canada; Recruiting

Burlington, Ontario, Canada; Active, not recruiting

Kitchener, Ontario, Canada; Active, not recruiting

Portland, Oregon, United States; Active, not recruiting

Medford, Oregon, United States; Active, not recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Nashville, Tennessee, United States; Active, not recruiting

San Antonio, Texas, United States; Recruiting

Austin, Texas, United States; Recruiting

Carrollton, Texas, United States; Recruiting

Fort Worth, Texas, United States; Active, not recruiting

Ogden, Utah, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Richmond, Virginia, United States; Recruiting

Mountlake Terrace, Washington, United States; Recruiting

Seattle, Washington, United States; Active, not recruiting

Milwaukee, Wisconsin, United States; Active, not recruiting

To learn how to participate in this trial please click here.

Starting date: July 2003
Ending date: June 2020
Last updated: September 25, 2009