Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate Aprepitant for the Prevention of Post Operative Nausea and Vomiting in Children (MK-0869-219)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01732458
First received: November 19, 2012
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine the appropriate dosing regimen of aprepitant for the prevention of post-operative nausea and vomiting in pediatric participants birth to 17 years.


Condition Intervention Phase
Post-Operative Nausea
Post-Operative Vomiting
Drug: Aprepitant
Drug: Placebo to match aprepitant
Drug: Ondansetron
Drug: Placebo to match ondansetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb, Partially-Blinded, Randomized, Active Comparator- Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Maximum (peak) plasma drug concentration (Cmax) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma concentration (Tmax) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve from time zero to infinity (AUC[0-∞]) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Apparent total clearance of the drug from plasma after oral administration (CL/F) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Aprepitant Terminal Phase Half-Life (t1/2) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aprepitant Dose 1

Dosing will be based on age and weight. The dose given will be the adult equivalent of 125 mg aprepitant.

A single dose of aprepitant (oral [PO]) and placebo matching ondansetron (intravenous [IV]) will be administered prior to induction of anesthesia.

Drug: Aprepitant
Other Names:
  • MK-0869
  • EMEND™
Drug: Placebo to match ondansetron
Experimental: Aprepitant Dose 2

Dosing will be based on age and weight. The dose given will be the adult equivalent of 40 mg aprepitant.

A single dose of aprepitant (PO) and placebo matching ondansetron (IV) will be administered prior to induction of anesthesia.

Drug: Aprepitant
Other Names:
  • MK-0869
  • EMEND™
Drug: Placebo to match ondansetron
Experimental: Aprepitant Dose 3

Dosing will be based on age and weight. The dose given will be the adult equivalent of 10 mg aprepitant.

A single dose of aprepitant (PO) and placebo matching ondansetron (IV) will be administered prior to induction of anesthesia.

Drug: Aprepitant
Other Names:
  • MK-0869
  • EMEND™
Drug: Placebo to match ondansetron
Experimental: Aprepitant Dose 4

Dosing will be based on age and weight. The dose given will be the adult equivalent of 2.5 mg aprepitant.

A single dose of aprepitant (PO) and placebo matching ondansetron (IV) will be administered prior to induction of anesthesia.

This dose will not be tested if submaximal efficacy is detected.

Drug: Aprepitant
Other Names:
  • MK-0869
  • EMEND™
Drug: Placebo to match ondansetron
Active Comparator: Ondansetron

4 mg for participants >40 kg in weight; 0.1 mg/kg for participants ≤40 kg in weight. In participants <1 month of age, the dose of ondansetron will be administered per the product label or based on local standard of care.

A single dose of ondansetron (IV) and placebo matching aprepitant (PO).

Drug: Placebo to match aprepitant Drug: Ondansetron
Other Name: Zofran

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of weight
  • Scheduled to receive general anesthesia AND must have at least one of the following risk factors for post-operative nausea and vomiting (PONV) in addition to receiving general anesthesia:

    1. scheduled to have a surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy; OR
    2. scheduled to have an operative procedure associated with PONV:

intraoperative opioid use or anticipated opioid administration within the first 24 hours following surgery.

Exclusion Criteria:

  • Emergency surgery for a life-threatening condition
  • Scheduled to receive propofol for maintenance of anesthesia (Note: propofol is permitted for induction of anesthesia).
  • Expected to receive opioid antagonists (e.g., naloxone, naltrexone) or

benzodiazepine antagonists (e.g., flumazenil)

  • Scheduled to undergo cardiac or neurosurgery
  • Vomiting caused by any organic etiology (such as gastric outlet

obstruction or small bowel obstruction)

  • Vomiting within 24 hours prior to surgery
  • Nasogastric or oral gastric tube intra- or post-operatively for suctioning

gastric contents

  • Active infection (e.g., pneumonia), congestive heart failure,

bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk to the participant

  • Use of any illicit drugs, including marijuana or has current evidence of alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732458

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Kentucky
Call for Information (Investigational Site 0031) Recruiting
Louisville, Kentucky, United States, 40202
United States, Texas
Call for Information (Investigational Site 0032) Recruiting
Austin, Texas, United States, 78723
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: Ricardo Germano    55 11 51897942      
Czech Republic
Merck Sharp and Dohme s.r.o. Recruiting
Praha, Czech Republic
Contact: Simona Martinkova    420 233010213      
Guatemala
MSD CARD Recruiting
Guatemala, Guatemala
Contact: Soraya Cedraro    507-282-7200      
Hungary
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Simona Martinkova    36 1 457 8522      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Cesar Sanz Rodriguez    34 913210600      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01732458     History of Changes
Other Study ID Numbers: 0869-219, 2011-006006-27
Study First Received: November 19, 2012
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Vomiting
Nausea
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
Fosaprepitant
Ondansetron
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014