Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00919113
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Information provided by (Responsible Party):
Watson Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Painful Bladder Syndrome Drug: 2% sodium chondroitin sulfate Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 8 weekly bladder instillations of Uracyst
20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
Drug: 2% sodium chondroitin sulfate
Weekly 20 mL Intravesical instillation
Other Name: Uracyst

Placebo Comparator: 8 weekly bladder instillations of inactive control
20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
Drug: Placebo
The identical buffer used in Uracyst for the same administration
Other Name: buffer

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. [ Time Frame: at week 11 ]
    Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00919113

Layout table for location information
United States, Colorado
Boulder, Colorado, United States, 80304
Denver, Colorado, United States, 80211
United States, Connecticut
Farmington, Connecticut, United States, 06032
United States, Florida
Plantation, Florida, United States, 33317
Wellington, Florida, United States, 33414
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Idaho
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Evanston, Illinois, United States, 60201
Melrose Park, Illinois, United States, 60160
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Englewood, New Jersey, United States, 07601
Sewell, New Jersey, United States, 08080
Westampton, New Jersey, United States, 08060
United States, New York
Albany, New York, United States, 12206
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
Watson Pharmaceuticals
Layout table for investigator information
Study Director: Lawrence A Hill, PharmD, MBA Watson Laboratories, Inc.
Layout table for additonal information
Responsible Party: Watson Pharmaceuticals Identifier: NCT00919113    
Other Study ID Numbers: UR08004
First Posted: June 12, 2009    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: May 3, 2013
Last Verified: May 2013
Keywords provided by Watson Pharmaceuticals:
Bladder Pain
GAG replacement therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis, Interstitial
Pathologic Processes
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases