- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00421148
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
August 8, 2018 updated by: Merck Sharp & Dohme LLC
A Multi-Center, Randomized, Parallel Dose-Finding, Safety Assessor-Blinded Trial to Explore the Efficacy, Safety and Pharmacokinetics of Four Doses of Org 25969 and Placebo in Pediatric and Adult Subjects.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
Experimental: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
Experimental: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
Experimental: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
Placebo Comparator: 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.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7
Time Frame: 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)
|
Neuromuscular functioning was monitored by applying repetitive 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 NMB.
A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
|
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
Time Frame: 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)
|
Neuromuscular functioning was monitored by applying repetitive 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 NMB.
A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2005
Primary Completion (Actual)
May 31, 2006
Study Completion (Actual)
June 2, 2006
Study Registration Dates
First Submitted
January 8, 2007
First Submitted That Met QC Criteria
January 8, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Actual)
January 28, 2019
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05961 (Other Identifier: Schering-Plough Protocol Number)
- 2004-003819-23 (EudraCT Number)
- 19.4.306 (Other Identifier: Organon Protocol Number)
- MK-8616-034 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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