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

NCT ID: NCT00421148

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-30
• Study Completion Date: 2006-06-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugammadex 0.5 mg/kg

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.

Group Type: EXPERIMENTAL

Sugammadex 0.5 mg/kg

Intervention Type: DRUG

IV infusion

Rocuronium bromide

Intervention Type: DRUG

IV infusion

Sugammadex 1 mg/kg

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.

Group Type: EXPERIMENTAL

Sugammadex 1 mg/kg

Intervention Type: DRUG

IV infusion

Rocuronium bromide

Intervention Type: DRUG

IV infusion

Sugammadex 2 mg/kg

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.

Group Type: EXPERIMENTAL

Sugammadex 2 mg/kg

Intervention Type: DRUG

IV infusion

Rocuronium bromide

Intervention Type: DRUG

IV infusion

Sugammadex 4 mg/kg

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.

Group Type: EXPERIMENTAL

Sugammadex 4 mg/kg

Intervention Type: DRUG

IV infusion

Rocuronium bromide

Intervention Type: DRUG

IV infusion

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion

Rocuronium bromide

Intervention Type: DRUG

IV infusion

Interventions

Sugammadex 0.5 mg/kg

IV infusion

Intervention Type: DRUG

Sugammadex 1 mg/kg

IV infusion

Intervention Type: DRUG

Sugammadex 2 mg/kg

IV infusion

Intervention Type: DRUG

Sugammadex 4 mg/kg

IV infusion

Intervention Type: DRUG

Placebo

IV infusion

Intervention Type: DRUG

Rocuronium bromide

IV infusion

Intervention Type: DRUG

Other Intervention Names

Org 25969; MK-8616; SCH 900616; Org 25969; MK-8616; SCH 900616; Org 25969; MK-8616; SCH 900616; Org 25969; MK-8616; SCH 900616; sodium chloride 0.9% solution; ESMERON®

Eligibility 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)

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.

Reference Type: RESULT

PMID: 19194156 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2004-003819-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19.4.306

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8616-034

Identifier Type: OTHER

Identifier Source: secondary_id

P05961

Identifier Type: OTHER

Identifier Source: secondary_id

P05961

Identifier Type: -

Identifier Source: org_study_id