Trial Details
RECRUITINGBasic Information
| Clinical ID | c1347 |
|---|---|
| Identifier | NCT04314375 |
| Trial Title | 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 |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NO |
|---|---|
| Conditions | Ulcerative Colitis |
| Interventions | DRUG: Low Dose Budesonide|DRUG: High Dose Budesonide|DRUG: Placebo |
Participant Information
| Sponsor | Bausch Health Americas, Inc. |
|---|---|
| City | Garden Grove |
| Country/Region | United States |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | CHILD |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE4 |
Time Information
| Start Date | 2023-09-29 |
|---|---|
| Primary Completion Date | 2025-12-24 |
| Completion Date | 2025-12-24 |