RecruitingPhase 4NCT04314375

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

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis


Sponsor

Bausch Health Americas, Inc.

Enrollment

70 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether budesonide extended-release tablets (an anti-inflammatory medication) are safe and effective for children and teenagers with mild to moderate active ulcerative colitis, a chronic inflammation of the large intestine. **You may be eligible if...** - You are between 5 and 17 years old and weigh more than 13.6 kg - You have been diagnosed with ulcerative colitis based on clinical, endoscopic, and biopsy findings - Your colitis is currently active but mild to moderate (Mayo score between 4 and 10) - Any current medications for colitis have been at a stable dose for at least 6 weeks **You may NOT be eligible if...** - You have Crohn's disease or indeterminate colitis (rather than ulcerative colitis) - Your disease only affects a very small area of the rectum (distal proctitis within 15 cm) - You have had surgery on your colon or rectum - You have serious infections or other significant medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose Budesonide

3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.

DRUGHigh Dose Budesonide

6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.

DRUGPlacebo

Matching placebo once daily.


Locations(4)

Bausch Health Site 008

Garden Grove, California, United States

Bausch Health Site 003

Indianapolis, Indiana, United States

Bausch Health Site 006

The Bronx, New York, United States

Bausch Health Site 010

Greenville, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT04314375


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