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Clinical trial

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen

NCT01532648 is registered in ClinicalTrials.gov with Bausch Health Americas, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen
Lead sponsor
Bausch Health Americas, Inc.
Phase
Phase 3
Overall status
Completed
Start date
January 27, 2012
Completion date
October 2, 2013
Enrollment
510 (actual)
Sites
114

Conditions

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

ulcerative colitis