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Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00248547
First received: November 3, 2005
Last updated: December 20, 2011
Last verified: December 2011
Results First Received: November 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Cancer
Interventions: Drug: aprepitant
Drug: dexamethasone
Drug: ondansetron
Drug: placebo

  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
Inpatients receiving allogeneic bone marrow transplants who were to get either Busulfan/Cytoxan or Cytoxan/Total Body Radiation as conditioning regimen.

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 Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Placebo Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant

Participant Flow:   Overall Study
    Aprepitant   Placebo
STARTED   20   20 
COMPLETED   20   20 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Aprepitant Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Placebo Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Total Total of all reporting groups

Baseline Measures
   Aprepitant   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (12.9)   46  (13)   46  (13) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   14   14   28 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures

1.  Primary:   Number of Emesis Free Participants During the Study Period.   [ Time Frame: Up to three weeks ]

2.  Secondary:   Safety in Transplant Population   [ Time Frame: Up to three weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Effects on Nausea, Appetite and Taste Changes   [ Time Frame: Up to three weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Pharmacokinetic Interaction   [ Time Frame: Up to three weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Joseph Bubalo, PharmD
Organization: Oregon Health & Science University, Knight Cancer Institute
phone: 503-494-1054
e-mail: bubaloj@ohsu.edu



Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00248547     History of Changes
Other Study ID Numbers: CDR0000445452
OHSU-HEM-03074-L ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-1057 ( Other Identifier: OHSU IRB )
MERCK-OHSU-HEM-03074-L ( Other Identifier: Merck )
Study First Received: November 3, 2005
Results First Received: November 21, 2011
Last Updated: December 20, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration