Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
NCT ID: NCT00086684
Last Updated: 2014-04-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
369 participants
INTERVENTIONAL
2003-09-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pentosan polysulfate sodium 100 mg once a day
One 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
One 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
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
Pentosan polysulfate sodium 100 mg
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
Placebo
Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
Placebo
One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks
Interventions
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Pentosan polysulfate sodium 100 mg
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
Placebo
One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks
Pentosan polysulfate sodium 100 mg
One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Birmingham, Alabama, United States
Homewood, Alabama, United States
Anchorage, Alaska, United States
San Bernardino, California, United States
San Carlos, California, United States
San Diego, California, United States
Torrance, California, United States
Denver, Colorado, United States
Longmont, Colorado, United States
Wheat Ridge, Colorado, United States
Newington, Connecticut, United States
Norwalk, Connecticut, United States
Celebration, Florida, United States
Longwood, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Trinity, Florida, United States
Venice, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Centralia, Illinois, United States
Evanston, Illinois, United States
Peoria, Illinois, United States
Jeffersonville, Indiana, United States
Dearborn, Michigan, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
St Louis, Missouri, United States
Henderson, Nevada, United States
West Orange, New Jersey, United States
Albany, New York, United States
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Winston-Salem, North Carolina, United States
Lima, Ohio, United States
Ponca City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Carrollton, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Mountlake Terrace, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Surrey, British Columbia, Canada
Victoria, British Columbia, Canada
Fredericton, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Kentville, Nova Scotia, Canada
Barrie, Ontario, Canada
Burlington, Ontario, Canada
Kingston, Ontario, Canada
Kitchener, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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C-2002-036
Identifier Type: OTHER
Identifier Source: secondary_id
CR004576
Identifier Type: -
Identifier Source: org_study_id
NCT00399139
Identifier Type: -
Identifier Source: nct_alias
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