Clinical Trial

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

Recruiting Phase 4
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-03-17; most recent amendment 2025-09-14.
Status change: Not Yet Recruiting → Recruiting 2023-10-05
Trial Details
NCT Number NCT04314375
Lead Sponsor Bausch Health Americas, Inc.
Conditions Ulcerative Colitis
Enrollment 70 participants
Start Date 2023-09-29
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-16