UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023054 |
|---|---|
| Receipt number | R000026402 |
| Scientific Title | The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone, a prospective randomized controlled study |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2019/02/17 16:01:54 |
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Basic information
Public title
The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone, a prospective randomized controlled study
Acronym
The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone
Scientific Title
The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone, a prospective randomized controlled study
Scientific Title:Acronym
The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone
Region
| Japan |
Condition
Condition
Cases requiring upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of l-mentol with dimethicone and without dimethicone for upper gastrointestinal endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination time
Key secondary outcomes
The presence or absence of bubble and the rate of side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The examination of upper gastrointestinal endoscopy underwent using l-mentol with 2% dimeticone
Interventions/Control_2
The examination of upper gastrointestinal endoscopy underwent that use l-mentol without 2% dimeticone
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases evaluated by upper gastrointestinal endoscopy.
Key exclusion criteria
The patient has allergy to l-mentol or 2% dimethicone.
Cases with severe complications are excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hattori Masashi |
Organization
Medical corporation Yamashita Hospital
Division name
Gastroenterology
Zip code
Address
1-3-5, Nakamachi, Ichinomiya
TEL
0586-45-4511
m.hattori@yamashita.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Esaki Masaya |
Organization
Medical corporation Yamashita Hospital
Division name
Gastroenterology
Zip code
Address
1-3-5, Nakamachi, Ichinomiya
TEL
0586-45-4511
Homepage URL
m.esaki@yamashita.or.jp
Sponsor or person
Institute
Medical corporation Yamashita Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical corporation Yamashita Hospital
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
| 2016 | Year | 07 | Month | 11 | 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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026402
| 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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| Registered date | File name |
