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Therapeutic Areas: Gastroenterology
Disease Category: Ulcerative Colitis
Trial Information
Efficacy and safety of new oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablet formulations in patients with mild or moderate, active ulcerative colitis. A multicenter, randomized, double-blind, double dummy comparative study versus placebo, with an additional reference arm evaluating Asacol® 2400 mg.
The study is to look at two doses of an extended release oral investigational medication for the treatment of ulcerative colitis.
Patient Inclusion Criteria:
- Be 18 to 75 years of age
- Be willing to have up to two colonoscopies
- Have mild to moderate ulcerative colitis for at least 6 months
Patient Exclusion Criteria: Currently receiving antibiotic therapy
Carolinas Research Associates
16633 Birkdale Commons Pkwy.
Huntersville, NC 28028
Phone: 704-366-3001
EMail: contact@carolinasresearch.com
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Research Center Information: Carolinas Research Associates
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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