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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013782
Receipt No. R000016086
Scientific Title Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.
Date of disclosure of the study information 2014/04/22
Last modified on 2019/06/21

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Basic information
Public title Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.
Acronym PROEMEND PK
Scientific Title Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.
Scientific Title:Acronym PROEMEND PK
Region
Japan

Condition
Condition Inoperable advanced/recurrence Gastric Cancer or Esophageal Cancer or Colorectal Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes * Blood concentration of dexamethasone
Key secondary outcomes * Frequency of vomiting
* Severity of nausea
* Grading of appetite
* Used amount of per-request medication

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A:
* 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day.
* 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day.
Interventions/Control_2 Group B:
* 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day.
* 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who receive the first cycle of chemotherapy with high emetic risk chemotherapy.
(2) Performance Status (ECOG)=0-2
Key exclusion criteria (1) Patient who is taking Pimozide.
(2) Patient who has severe liver failure or renal failure.
(3) Patient who had been treated with one moderate risk emetogenic antitumour drug according to the 2014 National Comprehensive Cancer Network Clinical Practice Guidelines.
(4) Patient who has vomited or provoked nausea in the 24 hours prior to start of chemotherapy.
(5) Patient who is considered inappropriate as a target patient by a physician-in-charge.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Goto
Organization Osaka Medical College Hospital
Division name Cancer Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Email in2030@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Goto
Organization Osaka Medical College Hospital
Division name Cancer Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki-City, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email in2030@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College Hospital
Institute
Department

Funding Source
Organization Osaka Medical College Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 11 Month 25 Day
Date of IRB
2014 Year 03 Month 03 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2018 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 22 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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