NCT06719622View on ClinicalTrials.gov

Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

July 30, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Crohn Disease (CD)
Interventions
DRUG

budesonide

1 mg budesonide ampoule twice daily for patients weighing ≤35 kg or 2 mg twice daily for patients weighing \>35 kg

DRUG

omeprazole (proton pump inhibitor)

omeprazole 10 mg twice daily for patients weighing ≤35 kg or 20 mg twice daily for patients weighing \>35 kg

Trial Locations (3)

30-663

Jagiellonian University, Krakow

60-572

Poznań University of Medical Sciences, Poznan

02-091

Medical University of Warsaw, Warsaw

All Listed Sponsors
collaborator

Jagiellonian University

OTHER

collaborator

Poznan University of Medical Sciences

OTHER

lead

Medical University of Warsaw

OTHER