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
NCT04314375
This study is recruiting at 4 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Ulcerative Colitis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 4
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Bausch Health Americas, Inc.
- Last updated on ClinicalTrials.gov
- September 16, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Bausch Health Site 008 · Garden Grove, CA
Indiana · 1
- Bausch Health Site 003 · Indianapolis, IN
New York · 1
- Bausch Health Site 006 · The Bronx, NY
North Carolina · 1
- Bausch Health Site 010 · Greenville, NC
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.