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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Interstitial Cystitis
Painful Bladder Syndrome
Interventions Drug: 2% sodium chondroitin sulfate
Drug: Placebo
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Uracyst Placebo
Hide Arm/Group Description 2% sodium chondroitin sulfate identical buffer
Period Title: Overall Study
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.
Arm/Group Title Uracyst Placebo Total
Hide Arm/Group Description 2% sodium chondroitin sulfate identical buffer Total of all reporting groups
Overall Number of Baseline Participants 49 49 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  91.8%
45
  91.8%
90
  91.8%
>=65 years
4
   8.2%
4
   8.2%
8
   8.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 49 participants 98 participants
44.4  (14.6) 46.8  (14.1) 45.6  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Female
49
 100.0%
49
 100.0%
98
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 49 participants 98 participants
49 49 98
1.Primary Outcome
Title Global Response Assessment (GRA) Responders at Week 11.
Hide Description subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
Time Frame at week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis performed according to randomized treatment.
Arm/Group Title Uracyst Placebo
Hide Arm/Group Description:
2% sodium chondroitin sulfate
identical buffer
Overall Number of Participants Analyzed 50 48
Measure Type: Number
Unit of Measure: participants
19 15
2.Secondary Outcome
Title Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
Hide Description Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF
Time Frame at week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis performed according to randomized treatment.
Arm/Group Title Uracyst Placebo
Hide Arm/Group Description:
2% sodium chondroitin sulfate
identical buffer
Overall Number of Participants Analyzed 50 48
Measure Type: Number
Unit of Measure: participants
23 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Uracyst Placebo
Hide Arm/Group Description

2% sodium chondroitin sulfate

One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.

identical buffer

One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.

All-Cause Mortality
Uracyst Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Uracyst Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/49 (2.04%)      2/49 (4.08%)    
Cardiac disorders     
Angina Pectoris  0/49 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorders     
Rectal Haemorrhage  1/49 (2.04%)  1 0/49 (0.00%)  0
Colitis  1/49 (2.04%)  1 0/49 (0.00%)  0
Psychiatric disorders     
Suicidal Ideation  0/49 (0.00%)  0 1/49 (2.04%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Uracyst Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/49 (42.86%)      18/49 (36.73%)    
Gastrointestinal disorders     
Nausea  4/49 (8.16%)  3/49 (6.12%) 
Constipation  1/49 (2.04%)  4/49 (8.16%) 
Psychiatric disorders     
Headache  1/49 (2.04%)  6/49 (12.24%) 
Renal and urinary disorders     
Dysuria  6/49 (12.24%)  4/49 (8.16%) 
Cystitis Interstitial  2/49 (4.08%)  4/49 (8.16%) 
Urinary Tract Infection  4/49 (8.16%)  2/49 (4.08%) 
Bladder Pain  4/49 (8.16%)  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders     
Sinusitis  8/49 (16.33%)  3/49 (6.12%) 
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.
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
ClinicalTrials.gov Identifier: NCT00919113     History of Changes
Other Study ID Numbers: UR08004
First Submitted: June 11, 2009
First Posted: June 12, 2009
Results First Submitted: February 5, 2013
Results First Posted: May 3, 2013
Last Update Posted: May 3, 2013