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Trial record 7 of 14 for:    "Testicular Germ Cell Cancer" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

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

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ClinicalTrials.gov Identifier: NCT00248547
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : December 21, 2011
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Cancer
Interventions Drug: aprepitant
Drug: dexamethasone
Drug: ondansetron
Drug: placebo
Enrollment 40
Recruitment Details Inpatients receiving allogeneic bone marrow transplants who were to get either Busulfan/Cytoxan or Cytoxan/Total Body Radiation as conditioning regimen.
Pre-assignment Details  
Arm/Group Title Aprepitant Placebo
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Aprepitant Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
46  (12.9) 46  (13) 46  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
6
  30.0%
6
  30.0%
12
  30.0%
Male
14
  70.0%
14
  70.0%
28
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Number of Emesis Free Participants During the Study Period.
Hide Description To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
Time Frame Up to three weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant Placebo (Sugar Pill)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
13 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aprepitant, Placebo (Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
2.Secondary Outcome
Title Safety in Transplant Population
Hide Description To assess the safety of aprepitant in the bone marrow transplant population
Time Frame Up to three weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Effects on Nausea, Appetite and Taste Changes
Hide Description To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.
Time Frame Up to three weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Pharmacokinetic Interaction
Hide Description To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
Time Frame Up to three weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aprepitant Placebo
Hide Arm/Group Description 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 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
All-Cause Mortality
Aprepitant Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aprepitant Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/20 (10.00%)   0/20 (0.00%) 
Gastrointestinal disorders     
Subileus  2/20 (10.00%)  0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aprepitant Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Joseph Bubalo, PharmD
Organization: Oregon Health & Science University, Knight Cancer Institute
Phone: 503-494-1054
EMail: bubaloj@ohsu.edu
Layout table for additonal information
Responsible Party: Joseph Bubalo, 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 )
First Submitted: November 3, 2005
First Posted: November 4, 2005
Results First Submitted: November 21, 2011
Results First Posted: December 21, 2011
Last Update Posted: May 9, 2017