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

This study has been completed.

Study NCT00248547 Information provided by OHSU Knight Cancer Institute

First Received on November 3, 2005. Last Updated on December 20, 2011 History of Changes

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
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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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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

Baseline Measures

	Aprepitant	Placebo	Total
Number of Participants [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 ]

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2. Secondary:

Safety in Transplant Population [ Time Frame: Up to three weeks ]

Results not yet posted. Anticipated Posting 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 posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Pharmacokinetic Interaction [ Time Frame: Up to three weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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 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.

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
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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

No publications provided

Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00248547 History of Changes
Other Study ID Numbers:	CDR0000445452, OHSU-HEM-03074-L, OHSU-1057, MERCK-OHSU-HEM-03074-L
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