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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 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 288 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03351608
The ClinicalTrials.gov registry entry for NCT03351608 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sugammadex 2 mg/kg is the first listed.
NCT03351608 reports 0 study locations.
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.
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