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

PHASE2CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

February 12, 2013

Primary Completion Date

September 26, 2016

Study Completion Date

September 26, 2016

Conditions
Post-operative NauseaPost-operative Vomiting
Interventions
DRUG

Aprepitant

Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.

DRUG

Placebo to Aprepitant

DRUG

Ondansetron

Administered IV at a dose of 4 mg for participants \>40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants \<1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.

DRUG

Placebo to match ondansetron

Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01732458 - A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219) | Biotech Hunter | Biotech Hunter