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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 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 145 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03909165
The ClinicalTrials.gov registry entry for NCT03909165 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 145 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.
NCT03909165 reports 0 study locations.
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.
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