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
Bausch Health Americas, Inc.
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
- Age range
- 5–17 years
- Sex
- All
- Healthy volunteers
- No
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…
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 008Garden Grove, California
- Bausch Health Site 003Indianapolis, Indiana
- Bausch Health Site 006The Bronx, New York
- Bausch Health Site 010Greenville, North Carolina