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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00919113
First received: June 11, 2009
Last updated: May 1, 2013
Last verified: May 2013

June 11, 2009
May 1, 2013
July 2009
December 2010   (final data collection date for primary outcome measure)
Global Response Assessment (GRA) Responders at Week 11. [ Time Frame: at week 11 ] [ Designated as safety issue: No ]
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
The primary effectiveness endpoint will be Global Response Assessment (GRA) responders at Week 11. [ Time Frame: At week 11 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00919113 on ClinicalTrials.gov Archive Site
Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. [ Time Frame: at week 11 ] [ Designated as safety issue: No ]
Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF
The secondary effectiveness endpoint will be Interstitial Cystitis Symptom Index (ICSI) responders at Week 11. [ Time Frame: At week 11 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Interstitial Cystitis
  • Painful Bladder Syndrome
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00919113
UR08004
No
Watson Pharmaceuticals
Watson Pharmaceuticals
Not Provided
Study Director: Lawrence A Hill, PharmD, MBA Watson Laboratories, Inc.
Watson Pharmaceuticals
May 2013

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