A Study of Aprepitant (MK0869) in Pediatric Participants Undergoing Surgery (0869-148 AM1)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00819039
First received: January 7, 2009
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting 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: Comparator: 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:
MedlinePlus related topics:
Nausea and Vomiting
Drug Information available for:
Ondansetron hydrochloride
Ondansetron
Aprepitant
Fosaprepitant
Fosaprepitant dimeglumine
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Post operative aprepitant plasma concentration levels and pharmacokinetic parameters; Safety and tolerability of Aprepitant [ Time Frame: up to 14 days following dosing of study medication ] [ Designated as safety issue: Yes ]
| Enrollment: | 100 |
| 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 I - Arm 1
Aprepitant (non-randomized, open label)
|
Drug: aprepitant
Adolescent Dose (12-17 years): 40 mg powder reconstituted to total volume of 5 mL of water, administered orally, as a single dose 1-3 hours before expected induction of anesthesia *Dosing for children under 12 years old will be based on body weight (15 mg + 1.1 mg/kg)
Other Name: Emend
|
|
Experimental: Part II - Arm 1
Aprepitant and Ondansetron placebo
|
Drug: aprepitant
Adolescent Dose (12-17 years): 40 mg powder reconstituted to total volume of 5 mL of water, administered orally, as a single dose 1-3 hours before expected induction of anesthesia *Dosing for children under 12 years old will be based on body weight (15 mg + 1.1 mg/kg)
Other Name: Emend
|
|
Active Comparator: Part II - Arm 2
Ondansetron and Aprepitant placebo
|
Drug: Comparator: Ondansetron
Single dose administration of ondansetron, 0.1 mg/kg up to 4mg by IV immediately prior to induction of anesthesia
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
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
Investigators
| Study Director: | Medical Monitor | Merck |
More Information
Additional Information:
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00819039 History of Changes |
| Other Study ID Numbers: | 0869-148, 2008_569 |
| Study First Received: | January 7, 2009 |
| Last Updated: | April 1, 2013 |
| 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 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