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Corticosteroid

Budesonide for Pediatric Ulcerative Colitis

Phase 4

Recruiting

Research Sponsored by Bausch Health Americas, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established diagnosis of UC based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies

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

Must not have

Severe UC, defined as total Mayo score >10

Evidence or history of toxic megacolon or bowel resection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial evaluates whether a new medication is safe and effective to treat ulcerative colitis in kids, while continuing existing treatments.

Who is the study for?

This trial is for kids aged 5-17 with mild to moderate ulcerative colitis, a type of inflammatory bowel disease. They must have specific symptoms and an established diagnosis based on medical history and tests. Kids should weigh over 13.6 kg and can continue their usual oral or rectal anti-inflammatory medication if stable for at least 6 weeks.

What is being tested?

The study is testing the effectiveness of budesonide extended-release tablets in inducing remission in children with ulcerative colitis. It's a randomized trial comparing two doses of budesonide against a placebo while allowing continued use of standard anti-inflammatory drugs.

What are the potential side effects?

Budesonide may cause side effects like headaches, nausea, abdominal pain, respiratory infections, fatigue, and behavioral changes. Long-term use might affect growth in children or lead to bone density loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ulcerative colitis based on my medical history, colonoscopy, and biopsy results.

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My ulcerative colitis is active but not severe, with symptoms like bleeding, frequent stools, and visible inflammation.

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I have been on the same 5-ASA medication for at least 6 weeks and am willing to stay on it.

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I am between 5 and 17 years old and weigh more than 13.6 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ulcerative colitis is severe, with a Mayo score over 10.

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I have had a toxic megacolon or part of my bowel removed.

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I have been diagnosed with Crohn's disease or indeterminate colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56.

Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56.

Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56.