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Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04314375
Study type Interventional
Source Bausch Health Americas, Inc.
Contact Sandra Narain
Phone 9082428287
Email sandra.narain@bauschhealth.com
Status Recruiting
Phase Phase 4
Start date September 29, 2023
Completion date December 2024

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