drugset / Trial / NCT04104646
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
RandomizedParallel-groupTriple-blindTreatment
Summary
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
Timeline
- Start
- 2020-12-18
- Primary completion
- 2021-12-13
- Completion
- 2021-12-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CHF6563 | Unknown | 10 ug/kg | Subcutaneous |
| Subject | CHF6563 | Unknown | 90 ug/kg | Subcutaneous |
| Comparator | Morphine | Other / unclassified | 0.07 mg/kg | Oral |