Trial Details
NOT_YET_RECRUITINGBasic Information
| Clinical ID | c1298 |
|---|---|
| Identifier | NCT05976802 |
| Trial Title | Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NO |
|---|---|
| Conditions | Ulcerative Colitis |
| Interventions | DRUG: High dose budesonide rectal foam|DRUG: Low dose budesonide rectal foam|DRUG: Matching placebo rectal foam |
Participant Information
| Sponsor | Bausch Health Americas, Inc. |
|---|---|
| City | - |
| Country/Region | - |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | CHILD |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE4 |
Time Information
| Start Date | 2025-06-24 |
|---|---|
| Primary Completion Date | 2025-06-25 |
| Completion Date | 2025-06-25 |