# 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** · PHASE4 · RECRUITING · sponsor: **Bausch Health Americas, Inc.** · enrollment: 70 (estimated)

## Conditions studied

- Ulcerative Colitis

## Interventions

- **DRUG:** Low Dose Budesonide
- **DRUG:** High Dose Budesonide
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04314375
- **Lead sponsor:** Bausch Health Americas, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-09-29
- **Primary completion:** 2026-12
- **Final completion:** 2027-06
- **Target enrollment:** 70 (ESTIMATED)
- **Last updated:** 2025-09-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04314375

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04314375. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*