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

Completed · Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis, Painful Bladder Syndrome

In brief

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.

Key facts

Study ID

NCT00919113

Run by

Watson Pharmaceuticals

People needed

98

Starts

2009-07-01

Expected to finish

2010-12-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Boulder, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Plantation, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Evanston, Illinois, United States
• Study site — Melrose Park, Illinois, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Englewood, New Jersey, United States
• Study site — Sewell, New Jersey, United States
• Study site — Woodlane, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Poughkeepsie, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Mountlake Terrace, Washington, United States

Full record on ClinicalTrials.gov

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