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A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527917
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : December 9, 2009
Information provided by:
Watson Pharmaceuticals

Brief Summary:
This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Device: placebo Device: Uracyst Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
Study Start Date : September 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Uracyst
Sodium chondroitin sulfate
Device: Uracyst
20 ml sterile solution for weekly intravesical instillation
Other Name: sodium chondroitin sulfate

Placebo Comparator: Placebo
Device: placebo
bladder instillation
Other Name: device vehicle

Primary Outcome Measures :
  1. Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis [ Time Frame: Baseline to 6 weeks ]

Secondary Outcome Measures :
  1. Adverse event assessments [ Time Frame: Throughout the study, first instillation to Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are female of male patient 18 years or older
  • 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:

  • Pregnant or lactating female.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00527917

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Canada, British Columbia
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Nova Scotia
Kentville, Nova Scotia, Canada
Canada, Ontario
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
Sponsors and Collaborators
Watson Pharmaceuticals
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Study Director: Keshava Kumar, PhD Watson Pharmaceuticals

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Responsible Party: Gary Hoel Ph.D. Executive Director, Watson Laboratories Inc Identifier: NCT00527917     History of Changes
Other Study ID Numbers: UR07001
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009

Keywords provided by Watson Pharmaceuticals:
Interstitial Cystitis/Painful Bladder Syndrome

Additional relevant MeSH terms:
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Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases