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

This study has been completed.
Information provided by (Responsible Party):
Watson Pharmaceuticals Identifier:
First received: June 11, 2009
Last updated: May 1, 2013
Last verified: May 2013
Results First Received: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Interventions: Drug: 2% sodium chondroitin sulfate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Uracyst 2% sodium chondroitin sulfate
Placebo identical buffer

Participant Flow:   Overall Study
    Uracyst     Placebo  
STARTED     50     48  
Received Uracyst     49 [1]   0  
Received Placebo     0     49 [1]
COMPLETED     41     40  
NOT COMPLETED     9     8  
[1] One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Uracyst 2% sodium chondroitin sulfate
Placebo identical buffer
Total Total of all reporting groups

Baseline Measures
    Uracyst     Placebo     Total  
Number of Participants  
[units: participants]
  49     49     98  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     45     45     90  
>=65 years     4     4     8  
[units: years]
Mean (Standard Deviation)
  44.4  (14.6)     46.8  (14.1)     45.6  (14.3)  
[units: participants]
Female     49     49     98  
Male     0     0     0  
Region of Enrollment  
[units: participants]
United States     49     49     98  

  Outcome Measures
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1.  Primary:   Global Response Assessment (GRA) Responders at Week 11.   [ Time Frame: at week 11 ]

2.  Secondary:   Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.   [ Time Frame: at week 11 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Gary Hoel, RPh PhD, VP Global Brands Clinical Research
Organization: Watson Laboratories, Inc.
phone: 801 588-6641

Responsible Party: Watson Pharmaceuticals Identifier: NCT00919113     History of Changes
Other Study ID Numbers: UR08004
Study First Received: June 11, 2009
Results First Received: February 5, 2013
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration