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

NCT00421148 | Completed Phase 3 Results FDA Drug

• 4 other identifiers: P059612004-003819-2319.4.306MK-8616-034
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9

  Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

  From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)

Secondary Outcomes (2)

• Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7

  From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration)

• Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8

  From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration)

Study Arms (5)

Sugammadex 0.5 mg/kg

EXPERIMENTAL

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.

Drug: Sugammadex 0.5 mg/kg; Drug: Rocuronium bromide

Sugammadex 1 mg/kg

EXPERIMENTAL

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.

Drug: Sugammadex 1 mg/kg; Drug: Rocuronium bromide

Sugammadex 2 mg/kg

EXPERIMENTAL

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.

Drug: Sugammadex 2 mg/kg; Drug: Rocuronium bromide

Sugammadex 4 mg/kg

EXPERIMENTAL

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.

Drug: Sugammadex 4 mg/kg; Drug: Rocuronium bromide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Rocuronium bromide

Interventions

Sugammadex 0.5 mg/kg DRUG

IV infusion

Also known as: Org 25969, MK-8616, SCH 900616

Sugammadex 0.5 mg/kg

Sugammadex 1 mg/kg DRUG

IV infusion

Also known as: Org 25969, MK-8616, SCH 900616

Sugammadex 1 mg/kg

Sugammadex 2 mg/kg DRUG

IV infusion

Also known as: Org 25969, MK-8616, SCH 900616

Sugammadex 2 mg/kg

Sugammadex 4 mg/kg DRUG

IV infusion

Also known as: Org 25969, MK-8616, SCH 900616

Sugammadex 4 mg/kg

Placebo DRUG

IV infusion

Also known as: sodium chloride 0.9% solution

Placebo

Rocuronium bromide DRUG

IV infusion

Also known as: ESMERON®

Placebo; Sugammadex 0.5 mg/kg; Sugammadex 1 mg/kg; Sugammadex 2 mg/kg; Sugammadex 4 mg/kg

Eligibility Criteria

• Age: 28 Days - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[or appropriate assent, if applicable\]

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 19194156 RESULT

MeSH Terms

Interventions

Sugammadex; Sodium Chloride; Solutions; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: May 30, 2005
• Primary Completion: May 31, 2006
• Study Completion: June 2, 2006
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share