UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021874 |
|---|---|
| Receipt number | 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 14:31:27 |
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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
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
odagiri-hki@umin.ac.jp
Public contact
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
odagiri-hki@umin.ac.jp
Sponsor or person
Institute
Hirosaki University School of Medicine and Hospital
Pharmaceutical department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025190
