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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074255
• Other study ID #: 0869-184
• Secondary ID: MK-0869-184
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: April 2, 2015
• Start date: April 2007
• Est. completion date: October 2011

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3546
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindication to EMEND

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting

Intervention

Drug:
• EMEND
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy	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).	Up to 14 days following the cessation of treatment	No