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An Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis.
This study is currently recruiting participants.
Verified by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., November 2009
First Received: November 10, 2006   Last Updated: November 19, 2009   History of Changes
Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier: NCT00399139
  Purpose

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.


Condition Intervention Phase
Interstitial Cystitis
Drug: pentosan polysulfate sodium
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 645
Study Start Date: July 2003
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399139

Contacts
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: info1@veritasmedicine.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
Active, not recruiting
Homewood, Alabama, United States
United States, Alaska
Recruiting
Anchorage, Alaska, United States
United States, California
Active, not recruiting
San Carlos, California, United States
Recruiting
Torrance, California, United States
Recruiting
San Diego, California, United States
Recruiting
La Jolla, California, United States
Active, not recruiting
San Bernardino, California, United States
United States, Colorado
Active, not recruiting
Denver, Colorado, United States
Active, not recruiting
Wheat Ridge, Colorado, United States
Active, not recruiting
Longmont, Colorado, United States
United States, Connecticut
Active, not recruiting
Norwalk, Connecticut, United States
Active, not recruiting
Newington, Connecticut, United States
United States, Florida
Active, not recruiting
Plantation, Florida, United States
Active, not recruiting
Weston, Florida, United States
Recruiting
Longwood, Florida, United States
Recruiting
New Port Richey, Florida, United States
United States, Georgia
Active, not recruiting
Atlanta, Georgia, United States
United States, Illinois
Active, not recruiting
Peoria, Illinois, United States
Active, not recruiting
Centralia, Illinois, United States
Active, not recruiting
Evanston, Illinois, United States
United States, Indiana
Active, not recruiting
Jeffersonville, Indiana, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, Missouri
Active, not recruiting
Saint Louis, Missouri, United States
United States, Nevada
Active, not recruiting
Henderson, Nevada, United States
United States, New Jersey
Active, not recruiting
West Orange, New Jersey, United States
United States, New York
Active, not recruiting
Albany, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
Recruiting
Winston Salem, North Carolina, United States
Active, not recruiting
Concord, North Carolina, United States
United States, Ohio
Active, not recruiting
Lima, Ohio, United States
United States, Oklahoma
Recruiting
Ponca City, Oklahoma, United States
Recruiting
Tulsa, Oklahoma, United States
United States, Oregon
Active, not recruiting
Portland, Oregon, United States
Active, not recruiting
Medford, Oregon, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
Active, not recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
San Antonio, Texas, United States
Recruiting
Austin, Texas, United States
Recruiting
Carrollton, Texas, United States
Active, not recruiting
Fort Worth, Texas, United States
United States, Utah
Recruiting
Ogden, Utah, United States
Recruiting
Salt Lake City, Utah, United States
United States, Virginia
Recruiting
Richmond, Virginia, United States
United States, Washington
Recruiting
Mountlake Terrace, Washington, United States
Active, not recruiting
Seattle, Washington, United States
United States, Wisconsin
Active, not recruiting
Milwaukee, Wisconsin, United States
Canada, Alberta
Active, not recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Active, not recruiting
Victoria, British Columbia, Canada
Recruiting
Surrey, British Columbia, Canada
Active, not recruiting
Kelowna, British Columbia, Canada
Canada, New Brunswick
Active, not recruiting
Fredericton, New Brunswick, Canada
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada
Active, not recruiting
Kentville, Nova Scotia, Canada
Canada, Ontario
Active, not recruiting
Toronto, Ontario, Canada
Recruiting
Newmarket, Ontario, Canada
Active, not recruiting
Barrie, Ontario, Canada
Active, not recruiting
Kitchener, Ontario, Canada
Active, not recruiting
Burlington, Ontario, Canada
Recruiting
Kingston, Ontario, Canada
Sponsors and Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR004576
Study First Received: November 10, 2006
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00399139     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:
Urinary Bladder Pain
Interstitial Cystitis

Additional relevant MeSH terms:
Cystitis, Interstitial
Anticoagulants
Urologic Diseases
Therapeutic Uses
Hematologic Agents
Urinary Bladder Diseases
Cystitis
Pharmacologic Actions
Pentosan Sulfuric Polyester

ClinicalTrials.gov processed this record on November 30, 2009