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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.
ClinicalTrials.gov Identifier: NCT00919113
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 11, 2009
First Posted Date  ICMJE June 12, 2009
Results First Submitted Date  ICMJE February 5, 2013
Results First Posted Date  ICMJE May 3, 2013
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
The primary effectiveness endpoint will be Global Response Assessment (GRA) responders at Week 11. [ Time Frame: at week 11 ]
Change History Complete list of historical versions of study NCT00919113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
The secondary effectiveness endpoint will be Interstitial Cystitis Symptom Index (ICSI) responders at Week 11. [ Time Frame: at week 11 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Cystitis
  • Painful Bladder Syndrome
Intervention  ICMJE
  • Drug: 2% sodium chondroitin sulfate
    Weekly 20 mL Intravesical instillation
    Other Name: Uracyst
  • Drug: Placebo
    The identical buffer used in Uracyst for the same administration
    Other Name: buffer
Study Arms  ICMJE
  • Experimental: 8 weekly bladder instillations of Uracyst
    20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
    Intervention: Drug: 2% sodium chondroitin sulfate
  • Placebo Comparator: 8 weekly bladder instillations of inactive control
    20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2013)
98
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
100
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919113
Other Study ID Numbers  ICMJE UR08004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Watson Pharmaceuticals
Study Sponsor  ICMJE Watson Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lawrence A Hill, PharmD, MBA Watson Laboratories, Inc.
PRS Account Watson Pharmaceuticals
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP