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

Phase 2

Completed

• Conditions: Interstitial Cystitis

• Registration Number: NCT00527917
• Lead Sponsor: Watson Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-07
• Last Update Posted: 2009-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis	Baseline to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse event assessments	Throughout the study, first instillation to Week 12