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

• Status: Completed
• Trial end date: 2006-06-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bromides; Rocuronium

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland

• Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg/kg rocuronium

• Scheduled for surgical procedures in the supine position

• Participants who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]

Exclusion Criteria:

• Known or suspected neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges

• Known or suspected to have a (family) history of malignant hyperthermia

• Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia

• Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration

• Pregnancy

• Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence

• Breast-feeding

• Prior participation in any study with Org 25969 (sugammadex)

• Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into study 19.4.306 (MK-8616-034, P05961)