UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007972 |
|---|---|
| Receipt number | R000009385 |
| Scientific Title | Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonicc mucosa for colonoscopy |
| Date of disclosure of the study information | 2012/05/18 |
| Last modified on | 2014/03/13 00:47:12 |
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Basic information
Public title
Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonicc mucosa for colonoscopy
Acronym
The RCT analyzing the efficacy of peppermint oil in colonoscopy
Scientific Title
Randomized study evaluating antiperistaltic effect of L-menthol sprayed onto the colonicc mucosa for colonoscopy
Scientific Title:Acronym
The RCT analyzing the efficacy of peppermint oil in colonoscopy
Region
| Japan |
Condition
Condition
Colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this RCT is to evaluate the antiperistaltic effect of L-menthol in colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Neoplasma detection rate (number of detected neoplasms per patient)
Key secondary outcomes
The observation time, degree of pain of the patient and peristalsis-suppressing effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
1.6% L-menthol
Interventions/Control_2
Water with dimeticon
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
Patients who have agreement to our study and undergo colonoscopy using 1.6% L-menthol randomly
Key exclusion criteria
Patient who is not able to undergo colonoscopy by other organs disorder, patient after colorectal surgery, patients with inflammatory bowel disease, patients with familial adenomatous polyposis
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tokita |
Organization
Kyoto Prefectural Yosanoumi Hospital
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
481, Otokoyama, Yosano-cho, Yosa-gunn, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Inoue |
Organization
Kyoto Prefectural Yosanoumi Hospital
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
481, Otokoyama, Yosano-cho, Yosa-gunn, Kyoto
TEL
0772-46-3371
Homepage URL
keninoue71@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural Yosanoumi Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural Yosanoumi 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
京都府立与謝の海病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24573731
Number of participants that the trial has enrolled
Results
L-menthol improves adenoma detection rate during colonoscopy.
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
| 2012 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 17 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2014 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009385
