UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013782 |
|---|---|
| Receipt number | 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 09:41:55 |
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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
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
in2030@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016086
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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