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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Sugammadex 1 mg/kg; Drug: Sugammadex 0.5 mg/kg; Drug: Sugammadex 4 mg/kg; Drug: Rocuronium bromide; Drug: Sugammadex 2 mg/kg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421148

P05961 (Other Identifier)

19.4.306 (Other Identifier)

2004-003819-23 (EudraCT Number)

MK-8616-034 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 28 days to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 5 patient groups, including a placebo group

Sugammadex 0.5 mg/kg

Experimental group

Description:

Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given.

Treatment:

Drug: Rocuronium bromide

Drug: Sugammadex 0.5 mg/kg

Sugammadex 1 mg/kg

Experimental group

Description:

Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given.

Treatment:

Drug: Rocuronium bromide

Drug: Sugammadex 1 mg/kg

Sugammadex 2 mg/kg

Experimental group

Description:

Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given.

Treatment:

Drug: Sugammadex 2 mg/kg

Drug: Rocuronium bromide

Sugammadex 4 mg/kg

Experimental group

Description:

Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given.

Treatment:

Drug: Rocuronium bromide

Drug: Sugammadex 4 mg/kg

Placebo

Placebo Comparator group

Description:

Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given.

Treatment:

Drug: Placebo

Drug: Rocuronium bromide