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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01074255
First received: February 22, 2010
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chemotherapy-induced Nausea and Vomiting
Drug: EMEND

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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).


Enrollment: 3546
Study Start Date: April 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other Names:
  • Aprepitant
  • MK-0869

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Korean patients treated with EMEND in usual practice.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to EMEND
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074255

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01074255     History of Changes
Other Study ID Numbers: 0869-184, MK-0869-184
Study First Received: February 22, 2010
Results First Received: August 31, 2012
Last Updated: June 2, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Nausea
Vomiting
Chemotherapy
Post-chemotherapy

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014