Tests budesonide tablets in children with mild to moderate ulcerative colitis
Tests budesonide tablets against placebo in children aged 5 to 17 with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Garden Grove, Greenville, Indianapolis, and The Bronx, United StatesSee the 4 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT04314375, who can take part
Where in United States
- Bausch Health Site 008Garden Grove, United StatesTaking people
- Bausch Health Site 010Greenville, United StatesTaking people
- Bausch Health Site 003Indianapolis, United StatesTaking people
- Bausch Health Site 006The Bronx, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bausch Health Americas, Inc.
- Trial code
- NCT04314375
- Record updated
- 16 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
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.
Exclusion: Current or prior diagnosis of Crohn's disease or indeterminate colitis; Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening); 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; Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge; 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; Evidence or history of toxic megacolon or bowel resection; Severe UC, defined as total Mayo score >10.