Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
|ClinicalTrials.gov Identifier: NCT01074255|
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : October 5, 2012
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment|
|Chemotherapy-induced Nausea and Vomiting||Drug: EMEND|
|Study Type :||Observational|
|Actual Enrollment :||3546 participants|
|Official Title:||Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Korean Participants Treated With EMEND (aprepitant)
Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist.
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.
- Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy [ Time Frame: Up to 14 days following the cessation of treatment ]The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074255
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|