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Trial record 6 of 7 for:    Balsalazide

Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

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: NCT00486031
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : January 19, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Inflammatory Bowel Disease
Ulcerative Colitis
Intervention Drug: Balsalazide Disodium
Enrollment 443
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Balsalazide Disodium Tabs,3.3 g BID
Hide Arm/Group Description Balsalazide Disodium tablets,3.3 g BID
Period Title: Overall Study
Started 443
Completed 440
Not Completed 3
Arm/Group Title Balsalazide Disodium Tabs,3.3 g BID,
Hide Arm/Group Description balsalazide disodium tablets,3.3 g BID,
Overall Number of Baseline Participants 440
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 440 participants
<65 years
412
  93.6%
>=65 years
28
   6.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 440 participants
Female
216
  49.1%
Male
224
  50.9%
1.Primary Outcome
Title Incidence of Treatment Emergent AEs
Hide Description Incidence of treatment emergent adverse events
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Balsalazide Disodium
Hide Arm/Group Description:
balsalazide disodium tablets,3.3 g BID,
Overall Number of Participants Analyzed 440
Measure Type: Number
Unit of Measure: participants
273
2.Secondary Outcome
Title Time to Onset of AEs
Hide Description Time to onset of adverse events
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected to perform this analysis
Arm/Group Title Balsalazide Disodium Tabs,3.3 g BID
Hide Arm/Group Description:
Balsalazide Disodium tablets,3.3 g BID
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Balsalazide Disodium
Hide Arm/Group Description balsalazide disodium tablets,3.3 g BID,
All-Cause Mortality
Balsalazide Disodium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Balsalazide Disodium
Affected / at Risk (%)
Total   21/440 (4.77%) 
Blood and lymphatic system disorders   
ANAEMIA  1/440 (0.23%) 
Cardiac disorders   
CARDIAC FAILURE CONGESTIVE  1/440 (0.23%) 
CHEST PAIN  1/440 (0.23%) 
VENTRICULAR DYSFUNCTION  1/440 (0.23%) 
Gastrointestinal disorders   
Colitis ulcerative  5/440 (1.14%) 
ABDOMINAL PAIN  2/440 (0.45%) 
Infections and infestations   
APPENDICITIS  1/440 (0.23%) 
Bronchitis  1/440 (0.23%) 
Cellulitis  2/440 (0.45%) 
CLOSTRIDIAL INFECTION  1/440 (0.23%) 
CLOSTRIDIUM COLITIS  1/440 (0.23%) 
INFLUENZA  1/440 (0.23%) 
PNEUMONIA  1/440 (0.23%) 
Injury, poisoning and procedural complications   
LOWER LIMB FRACTURE  1/440 (0.23%) 
Investigations   
PANCREATIC ENZYMES INCREASED  1/440 (0.23%) 
WEIGHT DECREASED  1/440 (0.23%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Balsalazide Disodium
Affected / at Risk (%)
Total   273/440 (62.05%) 
Gastrointestinal disorders   
Worsening UC  48/440 (10.91%) 
Diarrhea  27/440 (6.14%) 
Abdominal pain  26/440 (5.91%) 
Rectal haemorrhage  20/440 (4.55%) 
Nausea  13/440 (2.95%) 
Abdominal tenderness  9/440 (2.05%) 
Constipation  8/440 (1.82%) 
Dyspepsia  8/440 (1.82%) 
Hematochezia  7/440 (1.59%) 
Hemorrhoids  7/440 (1.59%) 
Infections and infestations   
Urinary tract infection  21/440 (4.77%) 
Nasopharyngitis  19/440 (4.32%) 
Upper respiratory tract infection  19/440 (4.32%) 
Sinusitis  15/440 (3.41%) 
Influenza  13/440 (2.95%) 
Bronchitis  8/440 (1.82%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  19/440 (4.32%) 
Back Pain  8/440 (1.82%) 
Nervous system disorders   
Headache  24/440 (5.45%) 
Dizziness  8/440 (1.82%) 
Product Issues   
Insomnia  8/440 (1.82%) 
Psychiatric disorders   
Depression  7/440 (1.59%) 
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain  7/440 (1.59%) 
Rash  11/440 (2.50%) 
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: Johnson Varughese
Organization: Valeant Pharmaceuticals
Phone: 9089271400
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00486031     History of Changes
Other Study ID Numbers: BZUC3005
First Submitted: June 11, 2007
First Posted: June 13, 2007
Results First Submitted: December 19, 2017
Results First Posted: January 19, 2018
Last Update Posted: August 15, 2019