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

Last updated: April 2, 2014
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Overall Status: Terminated

Phase

4

Condition

Gynecological Infections

Interstitial Cystitis

Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT00086684
CR004576
C-2002-036
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have a total score of 8 or greater on the O'Leary-Sant Interstitial CystitisSymptom 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 notrelated to a urinary tract infection, for at least 6 months prior to entry into thestudy

  • must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) andaveraged >= 1 void at night

  • urine culture showing no evidence of urinary tract infection

  • urine cytology showing no evidence of neoplastic cells

Exclusion

Exclusion Criteria:

  • Scheduled for or use of intravesical therapy (eg, bladder distention, dimethylsulfoxide) 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 mayaffect symptoms of interstitial cystitis (ie, antidepressants, antihistamines,antispasmodics, anticholinergics)

  • patients who are chronic users of Schedule II narcotics or who are using any schedulednarcotics at the time of study entry

  • patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such astissue plasminogen activator and streptokinase

Study Design

Total Participants: 369
Study Start date:
September 01, 2003
Estimated Completion Date:
June 30, 2011

Study 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

Connect with a study center

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Kelowna, British Columbia
    Canada

    Site Not Available

  • Surrey, British Columbia
    Canada

    Site Not Available

  • Victoria, British Columbia
    Canada

    Site Not Available

  • Fredericton, New Brunswick
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • Kentville, Nova Scotia
    Canada

    Site Not Available

  • Barrie, Ontario
    Canada

    Site Not Available

  • Burlington, Ontario
    Canada

    Site Not Available

  • Kingston, Ontario
    Canada

    Site Not Available

  • Kitchener, Ontario
    Canada

    Site Not Available

  • Newmarket, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Homewood, Alabama
    United States

    Site Not Available

  • Anchorage, Alaska
    United States

    Site Not Available

  • San Bernardino, California
    United States

    Site Not Available

  • San Carlos, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • Torrance, California
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Longmont, Colorado
    United States

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  • Wheat Ridge, Colorado
    United States

    Site Not Available

  • Newington, Connecticut
    United States

    Site Not Available

  • Norwalk, Connecticut
    United States

    Site Not Available

  • Celebration, Florida
    United States

    Site Not Available

  • Longwood, Florida
    United States

    Site Not Available

  • Plantation, Florida
    United States

    Site Not Available

  • Tampa, Florida
    United States

    Site Not Available

  • Trinity, Florida
    United States

    Site Not Available

  • Venice, Florida
    United States

    Site Not Available

  • Weston, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Centralia, Illinois
    United States

    Site Not Available

  • Evanston, Illinois
    United States

    Site Not Available

  • Peoria, Illinois
    United States

    Site Not Available

  • Jeffersonville, Indiana
    United States

    Site Not Available

  • Dearborn, Michigan
    United States

    Site Not Available

  • Grand Rapids, Michigan
    United States

    Site Not Available

  • Kalamazoo, Michigan
    United States

    Site Not Available

  • Saint Louis, Missouri
    United States

    Site Not Available

  • Henderson, Nevada
    United States

    Site Not Available

  • West Orange, New Jersey
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • Concord, North Carolina
    United States

    Site Not Available

  • Winston Salem, North Carolina
    United States

    Site Not Available

  • Lima, Ohio
    United States

    Site Not Available

  • Ponca City, Oklahoma
    United States

    Site Not Available

  • Tulsa, Oklahoma
    United States

    Site Not Available

  • Medford, Oregon
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Arlington, Texas
    United States

    Site Not Available

  • Austin, Texas
    United States

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  • Carrollton, Texas
    United States

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  • Fort Worth, Texas
    United States

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  • San Antonio, Texas
    United States

    Site Not Available

  • Ogden, Utah
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

  • Mountlake Terrace, Washington
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

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