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
- Interventions
- Device: placeboDevice: Uracyst
- 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
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
- Arm && Interventions
Group Intervention Description Placebo placebo placebo Uracyst Uracyst Sodium chondroitin sulfate
- 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