UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007048
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email k-nishizawa@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Pharmaceutical Sciences
Department of Clinical Pharmaceutics
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008307

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.