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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03909165




Registration number
NCT03909165
Ethics application status
Date submitted
8/04/2019
Date registered
9/04/2019

Titles & IDs
Public title
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
Scientific title
A Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years
Secondary ID [1] 0 0
MK-8616-169
Secondary ID [2] 0 0
8616-169
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular Blockade 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sugammadex 2 mg/kg
Treatment: Drugs - Sugammadex 4 mg/kg
Treatment: Drugs - Neostigmine + Glycopyrrolate
Treatment: Drugs - Neostigmine + Atropine

Experimental: Part A. Sugammadex 2 mg/kg - Single intravenous (IV) bolus of sugammadex at 2 mg/kg

Experimental: Part A. Sugammadex 4 mg/kg - Single IV bolus of sugammadex at 4 mg/kg.

Experimental: Part B. Sugammadex 2 mg/kg - Single IV bolus of sugammadex at 2 mg/kg.

Experimental: Part B. Sugammadex 4 mg/kg - Single IV bolus of sugammadex at 4 mg/kg.

Active comparator: Part B. Neostigmine - Single IV bolus containing neostigmine (50 µg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 µg/kg) or atropine sulfate (20 µg/kg).


Treatment: Drugs: Sugammadex 2 mg/kg
For moderate NMB reversal, a single IV bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.

Treatment: Drugs: Sugammadex 4 mg/kg
For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).

Treatment: Drugs: Neostigmine + Glycopyrrolate
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 µg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 µg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.

Treatment: Drugs: Neostigmine + Atropine
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 µg/kg; up to 5 mg maximum dose) as well as atropine (20 µg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A. Area Under the Plasma Concentration Time Curve (AUC) for Sugammadex
Timepoint [1] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [2] 0 0
Part A. Plasma Clearance (CL) of Sugammadex
Timepoint [2] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [3] 0 0
Part A. Apparent Volume of Distribution (Vz) for Sugammadex
Timepoint [3] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [4] 0 0
Part A. Apparent Volume of Distribution at Steady State (Vss) for Sugammadex
Timepoint [4] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [5] 0 0
Part A. Maximum Plasma Concentration (Cmax) of Sugammadex
Timepoint [5] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [6] 0 0
Part A. Half-Life (t1/2) of Sugammadex in Plasma
Timepoint [6] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [7] 0 0
Part B. Time to Neuromuscular Recovery
Timepoint [7] 0 0
Within Day 1
Primary outcome [8] 0 0
Parts A and B. Adverse Events (AEs)
Timepoint [8] 0 0
Up to 7 days
Secondary outcome [1] 0 0
Part B. Time to Extubation
Timepoint [1] 0 0
Within Day 1

Eligibility
Key inclusion criteria
* Categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.
* Has a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.
* Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring.
* Is male or female, between birth and <2 years of age.
Minimum age
1 Day
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is a preterm infant or neonate <36 weeks gestational age at birth.
* Has any clinically significant condition or situation (e.g., anatomical malformation that complicates intubation) other than the condition requiring the use of NMBA that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
* Has a neuromuscular disorder that may affect NMB and/or trial assessments.
* Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency.
* Has or is suspected of having a family or personal history of malignant hyperthermia.
* Has or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
* Is expected to require mechanical ventilation after the procedure.
* Has received or is planned to receive toremifene and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment.
* Use of medication expected to interfere with study treatments given in this trial.
* Has been previously treated with sugammadex or has participated in a sugammadex clinical trial within 30 days of signing the informed consent form of this current trial.
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2023
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Children s Hospital at Westmead ( Site 3805) - Westmead
Recruitment hospital [2] 0 0
Queensland Children s Hospital ( Site 3806) - South Brisbane
Recruitment hospital [3] 0 0
Royal Childrens Hospital Melbourne ( Site 3801) - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Vermont
Country [7] 0 0
Belgium
State/province [7] 0 0
Antwerpen
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles-Capitale, Region De
Country [9] 0 0
Belgium
State/province [9] 0 0
Vlaams-Brabant
Country [10] 0 0
Brazil
State/province [10] 0 0
Parana
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio Grande Do Sul
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Paulo
Country [13] 0 0
Denmark
State/province [13] 0 0
Hovedstaden
Country [14] 0 0
Finland
State/province [14] 0 0
Uusimaa
Country [15] 0 0
France
State/province [15] 0 0
Nord
Country [16] 0 0
Guatemala
State/province [16] 0 0
Guatemala
Country [17] 0 0
Hungary
State/province [17] 0 0
Csongrad
Country [18] 0 0
Hungary
State/province [18] 0 0
Debrecen
Country [19] 0 0
Malaysia
State/province [19] 0 0
Sarawak
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
Mexico
State/province [21] 0 0
Colima
Country [22] 0 0
Mexico
State/province [22] 0 0
Aguascalientes
Country [23] 0 0
Netherlands
State/province [23] 0 0
Gelderland
Country [24] 0 0
Netherlands
State/province [24] 0 0
Zuid-Holland
Country [25] 0 0
Netherlands
State/province [25] 0 0
Groningen
Country [26] 0 0
Netherlands
State/province [26] 0 0
Utrecht
Country [27] 0 0
Peru
State/province [27] 0 0
Lima
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Kemerovskaya Oblast
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moskva
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Sankt-Peterburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03909165