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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010018
Receipt No. R000011725
Scientific Title Antiemetic effectiveness and safety of aprepitant in patients with lung cancer receiving combination therapy with carboplatin.
Date of disclosure of the study information 2013/02/13
Last modified on 2013/02/11

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Basic information
Public title Antiemetic effectiveness and safety of aprepitant in patients with lung cancer receiving combination therapy with carboplatin.
Acronym Antiemetic effectiveness of aprepitant in patients recieving combination therapy with carboplatin
Scientific Title Antiemetic effectiveness and safety of aprepitant in patients with lung cancer receiving combination therapy with carboplatin.
Scientific Title:Acronym Antiemetic effectiveness of aprepitant in patients recieving combination therapy with carboplatin
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the antiemetic effect of aprepitant in patient with lung cancer recieving combination therapy with carboplatin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes antiemetic effect
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In initial treatment, patients are randomly allocated to receive newly antiemetic therapy with aprepitant or to recieve existing antiemetic therapy. In second treatment, all patients are received aprepitant.
Interventions/Control_2 In initial treatment, patients are randomly allocated to receive newly antiemetic therapy with aprepitant or to recieve existing antiemetic therapy. In second treatment, all patients are received aprepitant.
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 Pathologically confirmed inoperable stage IIIB or stage IV NSCLC
Adequate function of the bone marrow, liver and kidney.
Patients who can give a precise answer to a questionnaire about antiemetic effect.
Key exclusion criteria Patients with severe complications.
Patients with nausea and vomitting in the 24 hours before chemotherapy.
Patients received antiemetic therapy in the 48 hours before chemotherapy.
Patients with a risk of vomitting for other reasons. (active peptic ulcer and gastrointestinal obstruction, etc)
Target sample size 134

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama, Hamamatsu, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama, Hamamatsu, Japan
TEL
Homepage URL
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Other
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
2013 Year 02 Month 13 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 Completed
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 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 02 Month 12 Day
Last modified on
2013 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011725

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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