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NCT03909165 · ClinicalTrials.gov registry record · Phase 4
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
A Phase 4 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 145
- Enrollment target
NCT03909165: Completed Phase 4 study, sponsored by Merck Sharp & Dohme.
NCT03909165 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 145 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03909165, a Phase 4 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 145 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \<2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.
Primary Outcome
Pharmacokinetic (PK) blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-inf for sugammadex. As pre-specified by the Statistical Analysis Plan (SAP) for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).
Interventions
- DRUG Sugammadex 2 mg/kg
- DRUG Sugammadex 4 mg/kg
- DRUG Neostigmine + Glycopyrrolate
- DRUG Neostigmine + Atropine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2023-09-21 |
| Phase | Phase 4 |
What the finished NCT03909165 record still lists
NCT03909165 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Sugammadex 2 mg/kg is the first listed.
NCT03909165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03909165 about?
NCT03909165 is a clinical study titled "Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)". This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \<2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine i...
What is the current status of trial NCT03909165?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 145 participants. The study started on 2019-07-23. Estimated completion is 2023-09-21.
What interventions are being tested in trial NCT03909165?
The interventions under investigation include: Sugammadex 2 mg/kg (DRUG), Sugammadex 4 mg/kg (DRUG), Neostigmine + Glycopyrrolate (DRUG), Neostigmine + Atropine (DRUG).
Who is sponsoring clinical trial NCT03909165?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03909165's enrollment target sits among peer trials
145 573rd of 2000 higher than 1,424 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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