UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004565 |
|---|---|
| Receipt number | R000005450 |
| Scientific Title | A study of utility of Goukoku to hiccup with midazolam |
| Date of disclosure of the study information | 2010/11/22 |
| Last modified on | 2010/11/16 11:26:08 |
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Basic information
Public title
A study of utility of Goukoku to hiccup with midazolam
Acronym
A study of utility of Goukoku to hiccup with midazolam
Scientific Title
A study of utility of Goukoku to hiccup with midazolam
Scientific Title:Acronym
A study of utility of Goukoku to hiccup with midazolam
Region
| Japan |
Condition
Condition
Patient to whom hiccup continued for ten seconds or more for sedation of endoscopy with midazolam
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of utility of Goukoku whether hiccup with midazolam is improved
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disappearance rate of hiccup
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Being pushed Goukoku
Interventions/Control_2
Not being pushed Goukoku
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hiccup is contined for ten seconds or more with midazolam
Key exclusion criteria
The patient who take tranquillizers and chlorpromazines
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Sasaki |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Honjo,Kumamoto city,Kumamoto 860-8556,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Gushima |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Honjo,Kumamoto city,Kumamoto 860-8556,Japan
TEL
096-373-5150
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Faculty of Life Sciences,
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Faculty of Life Sciences,
Kumamoto University
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
YES
Study ID_1
385
Org. issuing International ID_1
Faculty of Life Sciences, Kumamoto University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
| 2010 | Year | 11 | Month | 16 | Day |
Last modified on
| 2010 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005450
| 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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