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New hope for kids with colitis: budesonide pill trial aims for remission

NCT ID NCT04314375

Disease control Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether budesonide extended-release tablets can safely help children aged 5 to 17 with mild to moderate ulcerative colitis achieve remission. About 70 participants will receive either a low dose, high dose, or placebo for 56 days. The goal is to reduce symptoms like rectal bleeding and frequent stools, with an endoscopic check to confirm improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
budesonide extended-release tablets
What this could lead to
If successful, this could provide a treatment option for children with mild to moderate ulcerative colitis to achieve remission without needing stronger drugs.
What could go wrong
This is a phase 4 study with only 70 participants, so results may not apply to all children. Budesonide is a steroid and can have side effects like growth suppression or hormonal changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: 1. Current or prior diagnosis of Crohn's disease or indeterminate colitis. 2. Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge. 3. Severe UC, defined as total Mayo score \>10. 4. Not currently in an active phase or flare, defined as a total Mayo score \<4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy. 5. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening). 6. Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical). NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening. 7. Evidence or history of toxic megacolon or bowel resection.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bausch Health Site 003

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Bausch Health Site 006

    RECRUITING

    The Bronx, New York, 10467, United States

  • Bausch Health Site 008

    RECRUITING

    Garden Grove, California, 92845, United States

  • Bausch Health Site 010

    RECRUITING

    Greenville, North Carolina, 27834, United States

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