Status:
COMPLETED
Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Interstitial Cystitis
Painful Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00919113
Start Date
July 1 2009
End Date
December 1 2010
Last Update
May 3 2013
Active Locations (20)
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1
Boulder, Colorado, United States, 80304
2
Denver, Colorado, United States, 80211
3
Farmington, Connecticut, United States, 06032
4
Plantation, Florida, United States, 33317