Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC) (KMEC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01636947
First received: July 5, 2012
Last updated: July 2, 2015
Last verified: July 2015
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Nausea
Vomiting
Interventions: Drug: Aprepitant
Drug: Aprepitant Placebo
Drug: Ondansetron
Drug: Dexamethasone
Drug: Ondansetron Placebo
Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aprepitant Regimen Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
Control Regimen Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.

Participant Flow:   Overall Study
    Aprepitant Regimen   Control Regimen
STARTED   244   250 
Treated   242   248 
COMPLETED   232   239 
NOT COMPLETED   12   11 
Not Treated                2                2 
Lost to Follow-up                4                0 
Protocol Violation                1                1 
Withdrawal by Subject                3                3 
Adverse Event                1                1 
Did Not Meet Eligibility Criteria                1                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Baseline Analysis Population consists of All Treated Participants. Two participants in each treatment group did not receive study drug.

Reporting Groups
  Description
Aprepitant Regimen Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
Control Regimen Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
Total Total of all reporting groups

Baseline Measures
   Aprepitant Regimen   Control Regimen   Total 
Overall Participants Analyzed 
[Units: Participants]
 242   248   490 
Age, Customized 
[Units: Participants]
     
20 to 29 years   4   3   7 
30 to 39 years   5   10   15 
40 to 49 years   32   28   60 
50 to 59 years   73   65   138 
60 to 69 years   74   77   151 
≥70 years   54   65   119 
Gender 
[Units: Participants]
     
Female   108   111   219 
Male   134   137   271 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With No Vomiting - Overall Stage   [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ]

2.  Secondary:   Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages   [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ]

3.  Secondary:   Number of Emetic Events - Overall Stage   [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ]

4.  Secondary:   Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage   [ Time Frame: Days 1 to Day 5 ]

5.  Secondary:   Percentage of Participants With No Impact on Daily Life - Overall Stage   [ Time Frame: Day 6 ]

6.  Secondary:   Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages   [ Time Frame: Day 1 to Day 5 ]

7.  Secondary:   Percentage of Participants With One or More Clinical Adverse Event   [ Time Frame: Day 1 through Day 29 (Up to 28 days after first dose of study drug) ]

8.  Secondary:   Percentage of Participants With No Vomiting - Acute and Delayed Stages   [ Time Frame: Day 1, Day 2 to Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01636947     History of Changes
Other Study ID Numbers: 0869-225
MK-0869-225 ( Other Identifier: Merck protocol number )
Study First Received: July 5, 2012
Results First Received: July 2, 2015
Last Updated: July 2, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)