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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
Results First Received: August 31, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Chemotherapy-induced Nausea and Vomiting
Intervention: Drug: EMEND

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 3,546 participants' case report forms were collected during the re-examination period (September 18, 2006 to January 22, 2012) from 33 hospitals in South Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
285 participants were excluded from study participation for the following reasons: violation of EMEND dosage/administration (242), assessed before the contracted date (20), duplicated participants (15), previously received EMEND (3), violated inclusion/exclusion criteria (3), and didn't receive EMEND (2).

Reporting Groups
  Description
Korean Participants Treated With EMEND (Aprepitant) EMEND (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.

Participant Flow:   Overall Study
    Korean Participants Treated With EMEND (Aprepitant)  
STARTED     3261  
COMPLETED     3261  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Korean Participants Treated With EMEND (Aprepitant) EMEND (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.

Baseline Measures
    Korean Participants Treated With EMEND (Aprepitant)  
Number of Participants  
[units: participants]
 		  3261  
Age, Customized  
[units: Participants]
 		 
<40 years     306  
40 to 49 years     671  
50 to 59 years     924  
60 to 69 years     989  
≥70 years     371  
Gender, Customized  
[units: Participants]
 		 
Male     1761  
Female     1499  
Not Recorded     1  



  Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck
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: August 31, 2012
Health Authority: Korea: Food and Drug Administration