Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
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
1 other identifier
interventional
98
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2009
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
May 3, 2013
CompletedMay 3, 2013
May 1, 2013
1.4 years
June 11, 2009
February 5, 2013
May 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Response Assessment (GRA) Responders at Week 11.
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
at week 11
Secondary Outcomes (1)
Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
at week 11
Study Arms (2)
8 weekly bladder instillations of Uracyst
EXPERIMENTAL20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
8 weekly bladder instillations of inactive control
PLACEBO COMPARATOR20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
Interventions
Weekly 20 mL Intravesical instillation
The identical buffer used in Uracyst for the same administration
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Boulder, Colorado, 80304, United States
Unknown Facility
Denver, Colorado, 80211, United States
Unknown Facility
Farmington, Connecticut, 06032, United States
Unknown Facility
Plantation, Florida, 33317, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Coeur d'Alene, Idaho, 83814, United States
Unknown Facility
Evanston, Illinois, 60201, United States
Unknown Facility
Melrose Park, Illinois, 60160, United States
Unknown Facility
Royal Oak, Michigan, 48073, United States
Unknown Facility
Las Vegas, Nevada, 89148, United States
Unknown Facility
Englewood, New Jersey, 07601, United States
Unknown Facility
Sewell, New Jersey, 08080, United States
Unknown Facility
Woodlane, New Jersey, 08060, United States
Unknown Facility
Albany, New York, 12206, United States
Unknown Facility
Poughkeepsie, New York, 12601, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Mountlake Terrace, Washington, 98043, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, RPh PhD, VP Global Brands Clinical Research
- Organization
- Watson Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Lawrence A Hill, PharmD, MBA
Watson Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 12, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
May 3, 2013
Results First Posted
May 3, 2013
Record last verified: 2013-05