Pediatric study to evaluate the appropriate dose for aprepitant in pediatric patients undergoing surgery.

Phase 1

• Conditions: Post Operative Nausea and Vomiting in surgical patients; MedDRA version: 14.1Level: LLTClassification code 10036901Term: Prophylaxis against postoperative nausea and vomitingSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-006006-27-HU
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-14
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Patient is birth (at least 37 weeks gestation and =3 kg of weight) to 17 years of age at the time of randomization.
2. 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 Surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy –OR-
o Operative procedure associated with PONV: intraoperative use or anticipated opioid administration within the first 24 following surgery.

Are the trial subjects under 18? yes
Number of subjects for this age range: 260
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 vomited within 24 hours prior to surgery.
6. Patient has an active infection (e.g., pneumonia), any uncontrolled disease (e.g., diabetic ketoacidosis, pre-existing gastrointestinal conditions/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/comparator to the patient.
7. 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 is routinely used for the type of surgery to be performed).
8. Patients with a know history of QT prolongation.
9. Patient is allergic to aprepitant, ondansetron or any 5-HT3 antagonist.
10. Patient is taking the anti-coagulant warfarin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified