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

Phase 2

Completed

• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Interventions: Drug: 2% sodium chondroitin sulfate; Drug: Placebo

• Registration Number: NCT00919113
• Lead Sponsor: Watson Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Study Start: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-02-05
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-01
• Last Update Submitted: 2013-05-01
• Results First Posted: 2013-05-03
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

• Are a female, 18 years or older
• Have been diagnosed with IC/PBS
• Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation

Exclusion Criteria

• Are lactating females
• Have previously received investigational products or devices within 30 days of screening
• Have previously received Uracyst
• Are currently receiving therapy with Interstim®
• Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
• Are unable or unwilling to comply with protocol requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 weekly bladder instillations of Uracyst	2% sodium chondroitin sulfate	20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
8 weekly bladder instillations of inactive control	Placebo	20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period

Primary Outcome Measures

Name	Time	Method
Global Response Assessment (GRA) Responders at Week 11.	at week 11	subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF

Secondary Outcome Measures

Name	Time	Method
Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.	at week 11	Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF