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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., October 2009
First Received: November 10, 2006   Last Updated: October 29, 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

  Show 60 Study Locations
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: October 29, 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.:
Interstitial Cystitis
Urinary Bladder Pain

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 09, 2009