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 Pharmaceuticals13 sites in 1 country65 target enrollmentStarted: September 1, 2007Last updated: December 9, 2009

Conditions

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor
Enrollment: 65
Locations: 13
Primary Endpoint: Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: 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.

Outcomes

Primary Outcomes

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 Outcomes

Adverse event assessments(Throughout the study, first instillation to Week 12)

Investigators

Sponsor

Watson Pharmaceuticals

Sponsor Class

Industry

Study Sites (13)

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