Clinical trial NCT00919113: Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Keywords: Bladder Pain
GAG replacement therapy
IC/PBS
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Global Response Assessment (GRA) Responders at Week 11.
timeFrame: at week 11
Secondary outcomes:
measure: Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
timeFrame: at week 11
Other outcomes:
Locations:
city: Boulder
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Plantation
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Coeur d'Alene
country: United States
state: Idaho
city: Evanston
country: United States
state: Illinois
city: Melrose Park
country: United States
state: Illinois
city: Royal Oak
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Englewood
country: United States
state: New Jersey
city: Sewell
country: United States
state: New Jersey
city: Westampton
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Mountlake Terrace
country: United States
state: Washington
Study officials:
affiliation: Watson Laboratories, Inc.
name: Lawrence A Hill, PharmD, MBA
role: STUDY_DIRECTOR
References: