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

December 7, 2009 updated by: Watson Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Nova Scotia
      • Kentville, Nova Scotia, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Device: placebo
bladder instillation
Other Names:
  • device vehicle
Experimental: Uracyst
Sodium chondroitin sulfate
Device: Uracyst
20 ml sterile solution for weekly intravesical instillation
Other Names:
  • sodium chondroitin sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event assessments
Time Frame: Throughout the study, first instillation to Week 12
Throughout the study, first instillation to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Keshava Kumar, PhD, Watson Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

December 9, 2009

Last Update Submitted That Met QC Criteria

December 7, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UR07001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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