drugset / Trial / NCT03999008
Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
RandomizedParallel-groupTriple-blindPrevention
Summary
The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.
Timeline
- Start
- 2020-06-01
- Primary completion
- 2022-06-01
- Completion
- 2023-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Budesonide | Small molecule | 250 ug | Oral |
| Comparator | Budesonide | Small molecule | 500 ug | Oral |
| Comparator | Budesonide | Small molecule | 1000 ug | Oral |