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Clinical Trials & Clinical Information
This information is intended for U.S. Healthcare Professionals only.
Clinical Trials
Major Safety and Efficacy Studies
- Green JRB, Lobo AJ, Holdsworth CD, et al. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology. 1998;114;1:15-22.
- Levine DS, Riff DS, Pruitt R, et al. A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis. Am J Gastroenterol. 2002;97;6:1398-1407.
The comparator drug formulation (mesalamine pH - dependent delayed release tablets) used in these studies is a UK formulation and is not the identical drug formulation currently approved in the U.S.
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Clinical Practice Guidelines
- The American Gastroenterological Association has published guidelines on the diagnosis and treatment of digestive disorders, as well as the use of diagnostic and therapeutic procedures in those disorders.
- Click here to access the American Gastroenterological Policy and Position Statements.
- The American College of Gastroenterology has published practice guidelines concerning various digestive disorders.
- Click here to access the American College of Gastroenterology Practice Parameters.
- The National Guideline Clearinghouse (NGC) is a public resource of evidence-based clinical practice guidelines. Practice guidelines are listed by the organization responsible for creating the guidelines and by disease.
- Click here to access the National Guideline Clearinghouse list of evidence-based clinical practice guidelines.
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Gastroenterology Algorithms
Quanta Healthcare Solutions, Inc. has recently developed (May 2002) a comprehensive resource of algorithms pertaining to various digestive diseases, among others. These algorithms were collected from the
biomedical literature, including research journals and textbooks. The Medical Algorithms Project contains more than 3500 algorithms for major therapeutic areas.
Click here for access to the Medical Algorithms Project.
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Clinical Information
The following case study is a report of a successful outcome with COLAZAL® (balsalazide disodium) Capsules 750 mg in a patient with a 14-year history of ulcerative colitis. The case study
details the patient's medical evaluations, diagnostic workups and treatment history prior to finding success with balsalazide disodium 6.75g daily.
Click here (PDF 83KB) to view "Patient with 14-year history of ulcerative colitis: successful outcome with balsalazide therapy" by Gary R.
Lichtenstein, MD, Associate Professor of Medicine, University of Pennsylvania School of Medicine, and Director, Center for Inflammatory Bowel Disease, Hospital of the University of Pennsylvania, Philadelphia.
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COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older.
COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events
(reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to
placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%),
nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of
COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
For product information, adverse event reports, and product complaint reports please call:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email:
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