A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00819039
First received: January 7, 2009
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Aprepitant
Drug: Ondansetron
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1 [ Time Frame: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose ] [ Designated as safety issue: No ]
    Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.

  • Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1 [ Time Frame: 48 Hours Post-Dose ] [ Designated as safety issue: No ]
    Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.

  • Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1 [ Time Frame: 48 Hours Post-Dose ] [ Designated as safety issue: No ]
    Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.

  • Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1 [ Time Frame: 24 Hours Post-Dose ] [ Designated as safety issue: No ]
    Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ).

  • Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1 [ Time Frame: 48 Hours Post-Dose ] [ Designated as safety issue: No ]
    The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.

  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 21 Days Post-Surgery ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to AEs [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 24 Hours ] [ Designated as safety issue: No ]
  • Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 24 Hours ] [ Designated as safety issue: No ]
    Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.

  • Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2 [ Time Frame: Up to 48 Hours ] [ Designated as safety issue: No ]
  • Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 48 Hours ] [ Designated as safety issue: No ]
    Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.

  • Number of Participants With Vomiting Frequency in Study Part 2 [ Time Frame: Up to 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: January 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Oral Aprepitant
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
Drug: Aprepitant
Aprepitant administered orally or intraveously.
Other Name: Emend
Experimental: Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
Drug: Aprepitant
Aprepitant administered orally or intraveously.
Other Name: Emend
Active Comparator: Part 2: Intravenous Ondansetron
In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.
Drug: Ondansetron
Ondansetron administered intravenously.
Other Name: Zofran

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour (Part II) hospital stay
  • Participant is scheduled to receive general anesthesia
  • Participant is scheduled to receive opioids (e.g. morphine or fentanyl)
  • Female participants of childbearing potential must have negative pregnancy test prior to drug administration
  • A female participant who is of reproductive potential must agree to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
  • Participant weighs 6 kg or more

Exclusion Criteria:

  • Participant is undergoing surgery for a life-threatening condition
  • Participant is pregnant or breast feeding
  • Participant has vomited within 24 hours prior to surgery
  • Participant has a known history of QT prolongation or is currently taking other medicinal products that lead to QT prolongation
  • Participant has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction), evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid obesity, that might pose unwarranted risk
  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: NCT00819039

Locations
United States, Kentucky
Call for Information (Investigational Site 0003)
Louisville, Kentucky, United States, 40202
United States, Tennessee
Call for Information (Investigational Site 0022)
Nashville, Tennessee, United States, 37232
Brazil
MSD
Sao Paulo, SP, Brazil, 04717-004
Mexico
MSD
Mexico City, Mexico, 1090
Spain
Merck Sharp and Dohme de Espana S.A.
Madrid, Spain, 28027
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul, Turkey
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00819039     History of Changes
Other Study ID Numbers: 0869-148, 2008_569, 2008-003178-17
Study First Received: January 7, 2009
Results First Received: December 23, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Ondansetron
Aprepitant
Fosaprepitant
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
Neurokinin-1 Receptor Antagonists

ClinicalTrials.gov processed this record on August 21, 2014