CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,546 enrolled
Drug / intervention
EMENDdrug
Likely dose
EMEND 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01074255
NCT01074255N/ACompleted
CompareCT.gov

Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice

Merck Sharp & Dohme LLC·observational·Posted Feb 24, 2010·Updated Apr 21, 2015

In Brief

An observational study evaluating EMEND for Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 3,546 participants.

Detailed Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-induced Nausea and Vomiting
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2010
Enrollment StartApr 1, 2007
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.4 years ago

Interventions

EMENDdrug

EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.