Re-examination Study of EMEND (Aprepitant) (MK-0869-184)

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: EMEND

• Registration Number: NCT01074255
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-24
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-08-31
• Results First Submitted QC: 2012-08-31
• Results First Posted: 2012-10-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3546

Inclusion Criteria

• Participants who are treated with EMEND for the first time as per the EMEND label

Exclusion Criteria

• Contraindication to EMEND

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Korean Participants Treated With EMEND (aprepitant)	EMEND	Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist.

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy	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).