A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
NCT ID: NCT00527917
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2007-09-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Uracyst
Sodium chondroitin sulfate
Uracyst
20 ml sterile solution for weekly intravesical instillation
Placebo
placebo
placebo
bladder instillation
Interventions
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placebo
bladder instillation
Uracyst
20 ml sterile solution for weekly intravesical instillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been previously diagnosed with IC/PBS.
* Are willing to provide informed consent
* Available for the duration of the study including treatment and follow-up (12 weeks)
Exclusion Criteria
* Are currently or have previously received investigational drugs within thirty (30) days of screening.
* Previous therapy for IC/PBS
* Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
* Are unable or unwilling to comply with protocol requirements
* Are unable to read, understand, and provide written informed consent.
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Watson Laboratories Inc
Principal Investigators
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Keshava Kumar, PhD
Role: STUDY_DIRECTOR
Watson Pharmaceuticals
Locations
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Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Kentville, Nova Scotia, Canada
Barrie, Ontario, Canada
Brantford, Ontario, Canada
Guelph, Ontario, Canada
Kingston, Ontario, Canada
Kitchener, Ontario, Canada
Newmarket, Ontario, Canada
North Bay, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Countries
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Other Identifiers
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UR07001
Identifier Type: -
Identifier Source: org_study_id