Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
NCT01074255 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3546
Last updated 2015-04-21
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.
Conditions
- Chemotherapy-induced Nausea and Vomiting
Interventions
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2011-10-31
- Completion
- 2011-10-31
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