UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012500 |
|---|---|
| Receipt number | R000014521 |
| Scientific Title | Effect of aprepitant for nausea and vomiting during Paclitaxel + Carboplatin (TC) therapy |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2013/12/05 14:14:24 |
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Basic information
Public title
Effect of aprepitant for nausea and vomiting during Paclitaxel + Carboplatin (TC) therapy
Acronym
Effect of aprepitant for nausea and vomiting during TC therapy
Scientific Title
Effect of aprepitant for nausea and vomiting during Paclitaxel + Carboplatin (TC) therapy
Scientific Title:Acronym
Effect of aprepitant for nausea and vomiting during TC therapy
Region
| Japan |
Condition
Condition
gynecologic malignancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To review utility of aprepitant for an antinausea effect during Paclitaxel + Carboplatin (TC) therapy for the patient with gynecological malignancy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effect of antiemesis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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 5HT3 receptor antagonist + dexamethasone iv
2nd course 5HT3 receptor antagonist + dexamethasone iv + aprepitant p.o.
Interventions/Control_2
Group B: 1st course 5HT3 receptor antagonist + dexamethasone iv + aprepitant p.o.
2nd course 5HT3 receptor antagonist + dexamethasone iv
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
Female
Key inclusion criteria
1.The patientwith gynecological malignancy that TC is taken as first line chemotherapy.
2.PS<2
Key exclusion criteria
1.PS>=2
2.the patient who were judged as inadequacy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Ohmichi |
Organization
Osaka Medical College
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
m-ohmichi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Kanemura |
Organization
Osaka Medical College
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
gyn044@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 05 | Day |
Last modified on
| 2013 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014521
