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

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ClinicalTrials.gov Identifier: NCT01074255
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : October 5, 2012
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment
Chemotherapy-induced Nausea and Vomiting Drug: EMEND

Study Design
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Study Type : Observational
Actual Enrollment : 3546 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074255


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01074255    
Other Study ID Numbers: 0869-184
MK-0869-184 ( Other Identifier: protocol number )
First Posted: February 24, 2010    Key Record Dates
Results First Posted: October 5, 2012
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Nausea
Vomiting
Chemotherapy
Post-chemotherapy
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Aprepitant
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action