drugset / Trial / NCT05814042
Next Generation ORS: Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea
Phase 2/3
Completed
396 enrolled
University of Florida
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Diarrhea remains a leading killer of children in need of better treatments.
Timeline
- Start
- 2023-08-21
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Outcome
Missed primary endpoint
registry analysis (superiority test); ORS With Calcium: Aim 1 vs ORS: Aim 1; p = 0.9941 NCT05814042 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Current standard control ORS | Unknown | — | Oral |
| Subject | Next Generation ORS | Unknown | — | Oral |