Study Stopped
Interim Analysis showed that study continuation was futile. No safety concerns were raised during the trial.
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
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
2 other identifiers
interventional
369
2 countries
65
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2003
Longer than P75 for phase_4
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 7, 2004
CompletedFirst Posted
Study publicly available on registry
July 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
July 6, 2012
CompletedApril 21, 2014
April 1, 2014
7.8 years
July 7, 2004
May 31, 2012
April 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint
The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.
Baseline to Week 24
Secondary Outcomes (1)
Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint
Baseline to Week 24
Study Arms (3)
Pentosan polysulfate sodium 100 mg once a day
EXPERIMENTALOne 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Pentosan polysulfate sodium 100 mg three times a day
EXPERIMENTALOne 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
Placebo
PLACEBO COMPARATORPlacebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
Interventions
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Homewood, Alabama, United States
Unknown Facility
Anchorage, Alaska, United States
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San Bernardino, California, United States
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San Carlos, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Longmont, Colorado, United States
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Wheat Ridge, Colorado, United States
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Newington, Connecticut, United States
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Norwalk, Connecticut, United States
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Celebration, Florida, United States
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Longwood, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Trinity, Florida, United States
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Venice, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Centralia, Illinois, United States
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Evanston, Illinois, United States
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Peoria, Illinois, United States
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Jeffersonville, Indiana, United States
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Dearborn, Michigan, United States
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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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West Orange, New Jersey, United States
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Albany, New York, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Lima, Ohio, United States
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Ponca City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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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
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Mountlake Terrace, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Fredericton, New Brunswick, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Kentville, Nova Scotia, Canada
Unknown Facility
Barrie, Ontario, Canada
Unknown Facility
Burlington, Ontario, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
Kitchener, Ontario, Canada
Unknown Facility
Newmarket, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Related Publications (1)
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PMID: 32734597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SENIOR DIRECTOR CLINICAL LEADER
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2004
First Posted
July 9, 2004
Study Start
September 1, 2003
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 21, 2014
Results First Posted
July 6, 2012
Record last verified: 2014-04