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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.

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00527917
First received: September 7, 2007
Last updated: December 7, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Interstitial Cystitis
 Device: placebo
Device: Uracyst
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event assessments [ Time Frame: Throughout the study, first instillation to Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uracyst
Sodium chondroitin sulfate
 Device: Uracyst
20 ml sterile solution for weekly intravesical instillation
Other Name: sodium chondroitin sulfate
Placebo Comparator: Placebo
placebo
 Device: placebo
bladder instillation
Other Name: device vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527917

Locations
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
Investigators
Study Director: Keshava Kumar, PhD Watson Pharmaceuticals
  More Information

No publications provided

Responsible Party: Gary Hoel Ph.D. Executive Director, Watson Laboratories Inc
ClinicalTrials.gov Identifier: NCT00527917     History of Changes
Other Study ID Numbers: UR07001
Study First Received: September 7, 2007
Last Updated: December 7, 2009
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 18, 2013