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A Study to Evaluate Aprepitant for the Prevention of Post Operative Nausea and Vomiting in Children (MK-0869-219 AM3)

This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01732458
First received: November 19, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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: December 2014
Estimated Primary Completion Date: November 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732458

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

Locations
United States, Ohio
Call for Information (Investigational Site 0030) Recruiting
Toledo, Ohio, United States, 43606
Chile
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Santiago, Chile
Contact: Maria Elena Azara Hernandez     56 2 6558958        
Hungary
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Simona Martinkova     36 1 457 8522        
Puerto Rico
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Carolina, Puerto Rico
Contact: Felipe Arbelaez     (787) 474-8200        
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Cesar Sanz Rodriguez     34 913210600        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01732458     History of Changes
Other Study ID Numbers: 0869-219, 2011-006006-27
Study First Received: November 19, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013