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.

Watson Pharmaceuticals0 sites65 target enrollmentSeptember 2007

ConditionsInterstitial Cystitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Interstitial Cystitis
Sponsor: Watson Pharmaceuticals
Enrollment: 65
Primary Endpoint: Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Watson Pharmaceuticals

Eligibility 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.