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Study details
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Study to Evaluate Budesonide for Ulcerative Colitis in Children

Bausch Health Americas, Inc.
NCT IDNCT04314375ClinicalTrials.gov data as of Apr 2026
Phase

Phase 4

Target enrollment

70

Study length

about 3.8 years

Ages

5–17

Locations

4 sites in CA, IN, NC +1

What this study is about

Researchers are testing a treatment called budesonide, which is a type of medication, to see if it helps children with mild to moderate ulcerative colitis. The trial will last 1370 days and involve about 70 children who have active ulcerative colitis.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take High Dose Budesonide
  • 2.Take Low Dose Budesonide
  • 3.Take Placebo

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

ALIMENTARY TRACT AND METABOLISM

Drug routes

oral (Delayed Release Oral Capsule)

Body systems

Gastroenterology