NCT00919113

Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Detailed description

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Conditions

• Interstitial Cystitis
• Painful Bladder Syndrome

Interventions

Type	Name	Description
DRUG	2% sodium chondroitin sulfate	Weekly 20 mL Intravesical instillation
DRUG	Placebo	The identical buffer used in Uracyst for the same administration

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-06-12
• Last updated: 2013-05-03
• Results posted: 2013-05-03

Locations

20 sites across 1 country: United States