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Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)

NCT00421148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-01-28

Study results available
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Summary

The purpose of this study is:

* to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants
* to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants.

Conditions

  • Anesthesia

Interventions

DRUG

Sugammadex 0.5 mg/kg

IV infusion

DRUG

Sugammadex 1 mg/kg

IV infusion

DRUG

Sugammadex 2 mg/kg

IV infusion

DRUG

Sugammadex 4 mg/kg

IV infusion

DRUG

Placebo

IV infusion

DRUG

Rocuronium bromide

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-30
Primary Completion
2006-05-31
Completion
2006-06-02
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00421148 on ClinicalTrials.gov