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Study identifier: NCT04314375 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Condition: Ulcerative Colitis  ·  Sponsor: Bausch Health Americas, Inc.

PhasePhase 4
Planned participants70
Who can joinAll sexes, 5 Years to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sandra Narain  ·  9082428287  ·  sandra.narain@bauschhealth.com

Always discuss trial participation with your own doctor first.

Locations (4)

Bausch Health Site 008Garden Grove, California, United StatesRecruiting
Bausch Health Site 003Indianapolis, Indiana, United StatesRecruiting
Bausch Health Site 006The Bronx, New York, United StatesRecruiting
Bausch Health Site 010Greenville, North Carolina, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04314375