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Clinical trial

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.

NCT00679432 is registered in ClinicalTrials.gov with Bausch Health Americas, Inc. as lead sponsor.

NCT NCT00679432
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Bausch Health Americas, Inc.
Phase
Phase 3
Overall status
Completed
Start date
June 30, 2008
Completion date
June 30, 2010
Enrollment
510 (actual)
Sites
105

Conditions

As the registry lists them; a condition with its own page is linked.

ulcerative colitis