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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.
First Received: September 7, 2007   Last Updated: November 6, 2008   History of Changes
Sponsor: Watson Pharmaceuticals
Information provided by: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00527917
  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: Uracyst
Device: placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:
  • The primary objective of this study is to evaluate the efficacy of Uracyst® relative to vehicle placebo in patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) using the Global Response Assessment instrument (GRA). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives of this study are to evaluate the efficacy of Uracyst® by using additional efficacy instruments and to collect additional safety data on the device. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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
1: Experimental
Uracyst
Device: Uracyst
solution for bladder instillation
2: Placebo Comparator
placebo
Device: placebo
bladder instillation

  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
Toronto, Ontario, Canada
Kitchener, Ontario, Canada
Barrie, Ontario, Canada
Guelph, Ontario, Canada
Brantford, Ontario, Canada
Newmarket, Ontario, Canada
Kingston, Ontario, Canada
Thunder Bay, Ontario, Canada
North Bay, Ontario, Canada
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Keshava Kumar, PhD Watson Pharmaceuticals
  More Information

No publications provided

Responsible Party: Watson Laboratories Inc ( Gary Hoel Ph.D. Executive Director )
Study ID Numbers: UR07001
Study First Received: September 7, 2007
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00527917     History of Changes
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Cystitis, Interstitial
Pathologic Processes
Disease
Urologic Diseases
Syndrome
Urinary Bladder Diseases
Cystitis

ClinicalTrials.gov processed this record on November 30, 2009