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

Not Applicable

• Conditions: -R11 Nausea and vomiting; Nausea and vomiting; R11

• Registration Number: PER-009-13
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patient is from birth (at least 37 weeks gestation and ≥3 kg of weight) to 17 years of age at the time of randomization.
2. Parent/guardian (legally authorized representative) agrees to the patient’s participation as indicated by parent/legal guardian signature on the informed consent form. Patients 12-17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures, and is willing to keep scheduled study visits. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in the Future Biomedical Research.
3. Patient is scheduled to receive general anesthesia AND:
Patients must have at least one of the following risk factors for PONV (in addition to receiving general anesthesia):
o Patient is scheduled to have a surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy.
–OR
o Patient is scheduled to have an operative procedure associated with PONV: intraoperative opioid use or anticipated opioid administration within the first 24 following surgery.
4. Patient falls within ASA Physical Status Classification I, II or III. (Appendix 6.1).
5. Female patient who has begun menses has a negative urine pregnancy test prior to randomization. Females of reproductive potential agree to remain abstinent or use a barrier form of contraceptive for at least 14 days prior to, throughout, and for at least 1 month following the last dose of study medication. Females taking oral contraceptive agents must agree to add a barrier form of contraception. For countries where abstinence is not considered an accepted method of birth control, a locally acceptable birth control method must be used.

Exclusion Criteria

1. Patient is undergoing emergency surgery for a life threatening condition.
2. Patient is scheduled to receive propofol for maintenance of anesthesia. (Note: propofol is permitted for induction of anesthesia).
3. Patient is expected to receive opioid antagonists (e.g., naloxone, naltrexone) or benzodiazepine antagonists (e.g., flumazenil).
4. Patient is scheduled to undergo cardiac or neurosurgery.
5. Patient has vomiting caused by any organic etiology (such as gastric outlet obstruction or small bowel obstruction).
6. Patient has vomited within 24 hours prior to surgery.
7. Patient is pregnant or breast-feeding. (Female patients of child bearing potential are required to have a negative urine pregnancy test prior to entering the study on the
morning of surgery).
8. Patient has a nasogastric or oral gastric tube intra- or post-operatively for suctioning gastric contents (Note: nasogastric or oral gastric tube intra- or post-operatively may ONLY be used for feeding. Patients should be excluded if a nasogastric or oral gastric tube for suctioning is routinely used for the type of surgery to be performed).
9. Patient has abnormal laboratory values as follows (deviations from these guidelines require discussion with the Merck Clinical Monitor):
a. Liver Function
- AST >1.5 x upper limit of normal for age.
- ALT >1.5 x upper limit of normal for age.
- Bilirubin >1.5 x upper limit of normal for age.
b. Renal Function
- Creatinine >1.5 x upper limit of normal for age
10. Patient has an 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 in administering study drug or concomitant therapy to the patient.
11. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that in the opinion of the investigator precludes study entry.
12. Patients with a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation.
13. Patient is currently a user of any illicit drugs, including marijuana or has current evidence of alcohol abuse (defined using DSM-IV criteria) as determined by the investigator.
14. Patient has ever participated in a study with aprepitant or fosaprepitant, is currently participating in a study with another NK-1 antagonist, or has taken a non-approved
(investigational) drug within the last 4 weeks.
15. Patient is allergic to aprepitant, ondansetron or any 5-HT3 antagonist.
16. Patient is taking the anti-coagulant warfarin.
17.-20. Other Excluded Medications: CYP3A4 inducers, CYP3A4 substrates, CYP3A4 inhibitors and antiemetics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified