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NCT03351608 · ClinicalTrials.gov registry record · Phase 4
Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
A Phase 4 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 288
- Enrollment target
NCT03351608: Completed Phase 4 study, sponsored by Merck Sharp & Dohme.
NCT03351608 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 288 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03351608, a Phase 4 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 288 participants
- Enrollment target
Study Summary
This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or vecuronium in pediatric participants. The primary efficacy hypothesis of this investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of ≥0.9.
Primary Outcome
The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.
Interventions
- DRUG Sugammadex 2 mg/kg
- DRUG Sugammadex 4 mg/kg
- DRUG Neostigmine + Glycopyrrolate
- DRUG Neostigmine + Atropine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2020-01-28 |
| Phase | Phase 4 |
What the finished NCT03351608 record still lists
NCT03351608 is an interventional study that assigns participants to a tested intervention. The registered 288 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 (44% lower).
The record links to 0 conditions, and to 4 interventions - of which Sugammadex 2 mg/kg is the first listed.
NCT03351608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03351608 about?
NCT03351608 is a clinical study titled "Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)". This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or vecuronium in pediatric participants. The primary efficacy hypothesis of this investigation is that sugammadex is ...
What is the current status of trial NCT03351608?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 288 participants. The study started on 2018-02-12. Estimated completion is 2020-01-28.
What interventions are being tested in trial NCT03351608?
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 NCT03351608?
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 NCT03351608's enrollment target sits among peer trials
288 298th of 2000 higher than 1,700 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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