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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.
Information provided by:
Watson Pharmaceuticals Identifier:
First received: September 7, 2007
Last updated: December 7, 2009
Last verified: December 2009
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
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.

Resource links provided by NLM:

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 ]

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

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
Device: placebo
bladder instillation
Other Name: device vehicle


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00527917

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
Study Director: Keshava Kumar, PhD Watson Pharmaceuticals
  More Information

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

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

Additional relevant MeSH terms:
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases processed this record on September 21, 2017