UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011609 |
|---|---|
| Receipt number | R000013581 |
| Scientific Title | Examination of Goukoku's usefulness to a hiccup which occurs at the time of using midazolam |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2016/10/05 15:50:53 |
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Basic information
Public title
Examination of Goukoku's usefulness to a hiccup which occurs at the time of using midazolam
Acronym
Examination of Goukoku's usefulness to a hiccup which occurs at the time of using midazolam
Scientific Title
Examination of Goukoku's usefulness to a hiccup which occurs at the time of using midazolam
Scientific Title:Acronym
Examination of Goukoku's usefulness to a hiccup which occurs at the time of using midazolam
Region
| Japan |
Condition
Condition
The patient who uses midazolam for a sedative of endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficasy of the pressure point called Goukoku for hiccup at the time of midazolam use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Disappearance of a hiccup
Key secondary outcomes
Time from a hiccup start to disappearance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Push the pressure point called Goukoku
Interventions/Control_2
Not push the pressure point called 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient whom hiccup followed 10 seconds or more when uses midazolam for a sedative of endoscopy.
Key exclusion criteria
A less than 20-year-old patient.
The patient who has taken medicine which makes hiccup improve, such as a tranquilizer and chlorpromazine.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Minato/Kouichi Nonaka |
Organization
NTT Medical Centor Tokyo
Division name
Department of Gastoroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo
TEL
03-3448-6111
yoheiminato55925@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Minato |
Organization
NTT Medical Centor Tokyo
Division name
Department of Gastoroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo
TEL
03-3448-6111
Homepage URL
yoheiminato55925@gmail.com
Sponsor or person
Institute
NTT Medical Centor Tokyo
Institute
Department
Personal name
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
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 | 09 | Month | 01 | 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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2016 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013581
