NCT00527917

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DEVICE	placebo	bladder instillation
DEVICE	Uracyst	20 ml sterile solution for weekly intravesical instillation

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2007-09-11
• Last updated: 2009-12-09

Locations

13 sites across 1 country: Canada