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

Condition(s) targeted: Interstitial Cystitis

Intervention: Pentosan polysulfate sodium 100 mg (Drug); Placebo (Drug); Pentosan polysulfate sodium 100 mg (Drug)

Phase: Phase 3

Status: Recruiting

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

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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: 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The proportion of patients with at least a 30% reduction in the patient-completed O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)

Secondary outcome:

Proportion of patients with at least a 4-point reduction in ICSI

Proportion of patients with >= 50% improvement in Patient Overall Rating of Improvement of Symptoms (PORIS)

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 vital 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; Completed

Anchorage, Alaska, United States; Recruiting

Edmonton, Alberta, Canada; Completed

Kelowna, British Columbia, Canada; Completed

Surrey, British Columbia, Canada; Recruiting

Victoria, British Columbia, Canada; Completed

La Jolla, California, United States; Recruiting

San Bernardino, California, United States; Completed

San Carlos, California, United States; Completed

San Diego, California, United States; Recruiting

Torrance, California, United States; Recruiting

Denver, Colorado, United States; Completed

Longmont, Colorado, United States; Completed

Wheat Ridge, Colorado, United States; Completed

Newington, Connecticut, United States; Completed

Norwalk, Connecticut, United States; Completed

Longwood, Florida, United States; Recruiting

New Port Richey, Florida, United States; Recruiting

Plantation, Florida, United States; Active, not recruiting

Weston, Florida, United States; Completed

Atlanta, Georgia, United States; Completed

Centralia, Illinois, United States; Completed

Evanston, Illinois, United States; Completed

Peoria, Illinois, United States; Terminated

Jeffersonville, Indiana, United States; Terminated

Detroit, Michigan, United States; Recruiting

Saint Louis, Missouri, United States; Terminated

Henderson, Nevada, United States; Completed

Fredericton, New Brunswick, Canada; Completed

West Orange, New Jersey, United States; Completed

Albany, New York, United States; Completed

Charlotte, North Carolina, United States; Recruiting

Concord, North Carolina, United States; Completed

Winston Salem, North Carolina, United States; Recruiting

Halifax, Nova Scotia, Canada; Completed

Kentville, Nova Scotia, Canada; Completed

Lima, Ohio, United States; Terminated

Ponca City, Oklahoma, United States; Recruiting

Tulsa, Oklahoma, United States; Recruiting

Barrie, Ontario, Canada; Completed

Burlington, Ontario, Canada; Completed

Kingston, Ontario, Canada; Recruiting

Kitchener, Ontario, Canada; Completed

Newmarket, Ontario, Canada; Recruiting

Toronto, Ontario, Canada; Completed

Medford, Oregon, United States; Completed

Portland, Oregon, United States; Completed

Philadelphia, Pennsylvania, United States; Recruiting

Nashville, Tennessee, United States; Completed

Austin, Texas, United States; Recruiting

Carrollton, Texas, United States; Recruiting

Fort Worth, Texas, United States; Completed

San Antonio, Texas, United States; 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; Completed

Milwaukee, Wisconsin, United States; Completed

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

Starting date: October 2003
Last updated: September 16, 2010