Evaluating Budesonide Tablets for Children with Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a randomized, double-blind, placebo-controlled trial aimed at assessing the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets in children aged 5 to 17 years who have active, mild to moderate ulcerative colitis. Participants will be allowed to continue their current treatment with oral or rectal 5-aminosalicylate products. The study will compare different doses of budesonide against a placebo to determine the best approach for inducing remission in these pediatric patients.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Sandra Narain
• Email: sandra.narain@bauschhealth.com
• Phone: 9082428287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.