drugset / Trial / NCT02401035
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
Timeline
- Start
- 2017-05-09
- Primary completion
- 2021-06-18
- Completion
- 2021-06-18
Outcome
Outcome not reported
Stopped (Enrollment): “Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 \<2 years of age cohort.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pantoprazole | Other / unclassified | 10 mg | Intravenous |
| Subject | Pantoprazole | Other / unclassified | 20 mg | Intravenous |
| Subject | Pantoprazole | Other / unclassified | 40 mg | Intravenous |