UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008317 |
|---|---|
| Receipt number | R000009792 |
| Scientific Title | The efficacy of L-menthol to control colonic spasm in colonoscopic examination |
| Date of disclosure of the study information | 2012/07/05 |
| Last modified on | 2018/09/05 20:19:42 |
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Basic information
Public title
The efficacy of L-menthol to control colonic spasm in colonoscopic examination
Acronym
The efficacy of L-menthol to control colonic spasm in colonoscopic examination
Scientific Title
The efficacy of L-menthol to control colonic spasm in colonoscopic examination
Scientific Title:Acronym
The efficacy of L-menthol to control colonic spasm in colonoscopic examination
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effectiveness of L-menthol to control colonic spasm in colonoscopic examination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the easiness of colonoscopic observation and the number of colonic spasm before and after spraying menthol.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
0.8% L-menthol
Interventions/Control_2
water
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
Patients who have agreement to our study and have a colorectal polyp
Key exclusion criteria
Patients who have serious other problems in their body.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohisa Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohisa Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 05 | 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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009792
