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Re-examination Study of EMEND (Aprepitant) (MK-0869-184 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01074255
First received: February 22, 2010
Last updated: August 31, 2012
Last verified: August 2012
History of Changes

February 22, 2010
August 31, 2012
April 2007
October 2011   (final data collection date for primary outcome measure)
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).
  • Investigator's assessment of response to therapy with EMEND for the prevention of acute and delayed nausea and vomiting (None, Poor, Fair, Good, Excellent) [ Time Frame: During or after first treatment ] [ Designated as safety issue: No ]
  • Percentage of patients with any clinical & laboratory adverse experience during or within 14 days following the cessation of treatment [ Time Frame: Up to 14 days cessation of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01074255 on ClinicalTrials.gov Archive Site
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Re-examination Study of EMEND (Aprepitant) (MK-0869-184 AM1)
Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice

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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Korean patients treated with EMEND in usual practice.
Chemotherapy-induced Nausea and Vomiting
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
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.
Intervention: Drug: EMEND
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3546
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to EMEND
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01074255
0869-184, MK-0869-184
No
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP