NCT04314375View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 29, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Ulcerative Colitis
Interventions
DRUG

Low Dose Budesonide

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

DRUG

High Dose Budesonide

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

DRUG

Placebo

Matching placebo once daily.

Trial Locations (4)

10467

RECRUITING

Bausch Health Site 006, The Bronx

27834

RECRUITING

Bausch Health Site 010, Greenville

46202

RECRUITING

Bausch Health Site 003, Indianapolis

92845

RECRUITING

Bausch Health Site 008, Garden Grove

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY

NCT04314375 - 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 | Biotech Hunter | Biotech Hunter