UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007048 |
|---|---|
| Receipt number | R000008307 |
| Scientific Title | Study of the relationship between antiemetic effect of Aprepitant and plasma concentration of Aprepitant |
| Date of disclosure of the study information | 2012/01/11 |
| Last modified on | 2015/01/13 21:34:56 |
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Basic information
Public title
Study of the relationship between antiemetic effect of Aprepitant and plasma concentration of Aprepitant
Acronym
Study of the relationship between antiemetic effect of Aprepitant and plasma concentration of Aprepitant
Scientific Title
Study of the relationship between antiemetic effect of Aprepitant and plasma concentration of Aprepitant
Scientific Title:Acronym
Study of the relationship between antiemetic effect of Aprepitant and plasma concentration of Aprepitant
Region
| Japan |
Condition
Condition
Malignant tumor(esophageal cancer,gastric cancer etc.)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the efficacy of Aprepitant and plasma concentration in prevention of cisplatin induced emesis
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate in overall phase
(0-120 hours after chemotherapy)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Palonosetron:day1(0.75mg)
Aprepitant:day1(125mg),2(80mg),3(80mg)
Dexamethasone:day1(9.9mg)
Dexamethasone:day2-4(8mg)
Interventions/Control_2
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 chemotherapy involving cisplatin(>=50mg/m2)
2)20 years-old over at the time of giving informed consent
3)Informed consent by the document
Key exclusion criteria
1)Receiving an antiemetic drug
2)Receiving an opioid
3)Any patients judged by the investigator to be unfit to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosuke Nishizawa |
Organization
Toho University School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmaceutics
Zip code
Address
2-2-1,Miyama,Funabashi-city,Chiba 274-8510,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Nishizawa |
Organization
Toho University School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmaceutics
Zip code
Address
TEL
Homepage URL
k-nishizawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Pharmaceutical Sciences
Department of Clinical Pharmaceutics
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2012 | Year | 01 | Month | 11 | 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
Results
No significant differences were found between the two groups in the percentage of CINV prevention.
Of the 13 patients who experienced CINV, the highconcentration group showed a significant improvement in CINV during the aprepitant administration term.
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
| 2011 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 11 | Day |
Last modified on
| 2015 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008307
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
