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Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

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ClinicalTrials.gov Identifier: NCT01012336
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Samsung Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chemotherapy-Induced Nausea and Vomiting
Ovarian Cancer
Intervention Drug: Aprepitant/Ramosetron/Dexamethasone
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aprepitant
Hide Arm/Group Description Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
Period Title: Overall Study
Started 85
Completed 85
Not Completed 0
Arm/Group Title Aprepitant
Hide Arm/Group Description Aprepitant is a selective, high-affinity NK1 receptor antagonist
Overall Number of Baseline Participants 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
<=18 years
0
   0.0%
Between 18 and 65 years
69
  81.2%
>=65 years
16
  18.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants
54.9  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
Female
85
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 85 participants
85
1.Primary Outcome
Title Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.
Hide Description Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).
Time Frame 120 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant
Hide Arm/Group Description:
Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: Percentage of Participants
89.4
2.Primary Outcome
Title Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen
Hide Description [Not Specified]
Time Frame 120 hours
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy
Hide Description [Not Specified]
Time Frame 120 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to First Vomiting Episode or Use of Rescue Medication
Hide Description [Not Specified]
Time Frame 120 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aprepitant
Hide Arm/Group Description Aprepitant is a selective, high-affinity NK1 receptor antagonist
All-Cause Mortality
Aprepitant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aprepitant
Affected / at Risk (%) # Events
Total   2/89 (2.25%)    
Blood and lymphatic system disorders   
Neutropenic fever  2/89 (2.25%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Aprepitant
Affected / at Risk (%) # Events
Total   35/89 (39.33%)    
Gastrointestinal disorders   
constipation  14/89 (15.73%)  14
General disorders   
fatigue  13/89 (14.61%)  13
Nervous system disorders   
headache  12/89 (13.48%)  12
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Pf Duk-Soo Bae
Organization: Samsung Medical Center
Phone: 82-2-3410-3519
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01012336     History of Changes
Other Study ID Numbers: 2009-09-119
First Submitted: November 10, 2009
First Posted: November 13, 2009
Results First Submitted: August 29, 2012
Results First Posted: October 10, 2012
Last Update Posted: October 10, 2012