Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)



Status:Recruiting
Healthy:No
Age Range:2 - 16
Updated:4/5/2019
Start Date:February 12, 2018
End Date:August 11, 2020
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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

This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the
reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium
or vecuronium in pediatric participants. The primary efficacy hypothesis of this
investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in
pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of
≥0.9.

This trial will be conducted in two parts: Part A and Part B. In Part A, pharmacokinetic (PK)
sampling will be conducted to identify the pediatric dose providing sugammadex exposure
similar to adults. For Part B participants, the efficacy of sugammadex (i.e. time to recovery
of the TOF ratio) will be assessed. Further, safety analyses will be conducted in both Parts
A and B. Following completion of Part A, an interim analysis (IA) of the PK and safety data
will be performed. Once the appropriate doses are confirmed and safety data is assessed for
the 2 doses of sugammadex, then Part B will commence.

Inclusion Criteria:

- Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1,
2, or 3.

- Have a planned non-emergent surgical procedure or clinical situation (e.g.,
intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.

- Have a planned surgical procedure or clinical situation that would allow objective
neuromuscular monitoring techniques to be applied with access to the arm for
neuromuscular transmission monitoring.

- Age between 2 to <17 years at Visit 2.

- If female, may participate if she is not pregnant, not breastfeeding, and at least one
of the following: 1) Not a woman of childbearing potential (WOCBP); or 2) A WOCBP who
agrees to follow the study contraceptive guidance during the treatment period and for
at least 7 days after the last dose of study treatment.

Exclusion Criteria:

- Has any clinically significant condition or situation (eg, anatomical malformation
that complicates intubation) other than the condition being studied 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
(defined as estimated glomerular filtration rate (eGFR) <30 ml/min).

- 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.

- 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.

- Has been previously treated with sugammadex or has participated in a sugammadex
clinical 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.
We found this trial at
8
sites
New Brunswick, New Jersey 08901
Phone: 732-745-8600
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-8649
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Phone: 412-692-6390
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Ann Arbor, Michigan 48109
Phone: 734-763-2435
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-4877
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Palo Alto, California 94304
Phone: 650-724-2320
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Warendorf,
Phone: +492581202233
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Phone: 202-476-2025
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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