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Budesonide Extended-Release for Pediatric Ulcerative Colitis

This study is testing budesonide extended-release tablets in children aged 5 to 17 years who have mild to moderate ulcerative colitis (UC), a condition causing inflammation in the large intestine. Researchers want to see how safe and effective two different doses of budesonide are compared to a placebo (an inactive pill). You might be able to join if you have been diagnosed with UC, are between 5 and 17 years old, and your UC is considered mild to moderate. The main goal is to see how many participants achieve "clinical remission" (a significant improvement in symptoms) after 56 days. The study is currently unclear about its recruitment status and plans to enroll about 70 participants.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive budesonide or placebo, and neither you nor your doctor will know which you are receiving. It aims to enroll about 70 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 56 days, indicating follow-up for at least this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04314375

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

Recruiting
PHASE4Ages 5–17InterventionalTreatment
Bausch Health Americas, Inc.
~70 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Low Dose BudesonideHigh Dose BudesonidePlacebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.
Measured over 56 days

Conditions

Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

4 sites across 4 states
California1
Indiana1
New York1
North Carolina1

Study leadership

  • Varsha Bhatt · STUDY_DIRECTOR · Bausch Health Americas, Inc.

Who to contact

Sandra Narain
[email protected]
9082428287
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Established diagnosis of UC is based on:
Clinical history
Characteristic endoscopic findings
Histopathology results from biopsies
Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.
Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.
If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.

What this trial measures

  • The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.56 days

    The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.