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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021874
Receipt No. R000025190
Scientific Title Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Date of disclosure of the study information 2016/04/12
Last modified on 2016/12/11

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Basic information
Public title Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Acronym Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Scientific Title Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Scientific Title:Acronym Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Region
Japan

Condition
Condition Malignancy
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is the evaluate the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examinaion of the method for decreasing the remaining alcohol.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Breath alcohol concentration
Key secondary outcomes Subjective symptom

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Measuring the breath alcohol concentration 1-3 times after an intravenous injection of paclitaxel
Measuring the breath alcohol concentration similarly after drinking water
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient who get treatment with paclitaxel
Key exclusion criteria The patient by whom consent can't be obtained
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Nao Odagri
Organization Hirosaki University School of Medicine and Hospital
Division name Pharmaceutical department
Zip code
Address 53 Hon-cho, Hirosaki, Aomori
TEL 0172-33-5111
Email odagiri-hki@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Nao Odagri
Organization Hirosaki University School of Medicine and Hospital
Division name Pharmaceutical department
Zip code
Address 53 Hon-cho, Hirosaki, Aomori
TEL 0172-33-5111
Homepage URL
Email odagiri-hki@umin.ac.jp

Sponsor
Institute Hirosaki University School of Medicine and Hospital
Pharmaceutical department
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2016 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 28 Day
Last follow-up date
2016 Year 11 Month 30 Day
Date of closure to data entry
2016 Year 12 Month 11 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 11 Day
Last modified on
2016 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025190

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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