Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
NCT05976802 is registered in ClinicalTrials.gov with Bausch Health Americas, Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
- Lead sponsor
- Bausch Health Americas, Inc.
- Phase
- Phase 4
- Overall status
- Not yet recruiting
- Start date
- June 30, 2029
- Completion date
- January 31, 2031
- Enrollment
- 100 (estimated)
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.
ulcerative colitis