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
Overview
- Phase
- Phase 2
- Intervention
- 2% sodium chondroitin sulfate
- Conditions
- Interstitial Cystitis
- Sponsor
- Watson Pharmaceuticals
- Enrollment
- 98
- Primary Endpoint
- Global Response Assessment (GRA) Responders at Week 11.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
8 weekly bladder instillations of Uracyst
20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
Intervention: 2% sodium chondroitin sulfate
8 weekly bladder instillations of inactive control
20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
Intervention: Placebo
Outcomes
Primary Outcomes
Global Response Assessment (GRA) Responders at Week 11.
Time Frame: at week 11
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
Secondary Outcomes
- Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.(at week 11)