Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice|
- 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 ] [ Designated as safety issue: No ]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).
|Study Start Date:||April 2007|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074255
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|