UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029125 |
|---|---|
| Receipt number | R000028192 |
| Scientific Title | A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP. |
| Date of disclosure of the study information | 2017/09/26 |
| Last modified on | 2017/09/13 11:15:43 |
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Basic information
Public title
A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP.
Acronym
The usefulness of l-menthol in ERCP
Scientific Title
A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP.
Scientific Title:Acronym
The usefulness of l-menthol in ERCP
Region
| Japan |
Condition
Condition
Bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the validity and safety of l-menthol as antispasmodic drug in ERCP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of complete procedure planned without additional antispasmodic drugs
Key secondary outcomes
Time to deep cannulation into common bile duct or pancreatic duct
total procedure time
Complications related to the procedures
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
l-menthol
Interventions/Control_2
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 performed diagnostic ERCP for pancreatic or biliary diseases.
Key exclusion criteria
1) Patients with previous gastrectomy.
2) Patients with allergic for l-menthol.
3) Patients with severe complications of other organs.
4) Pregnant patients or patients who were suspected pregnancy.
5) Patients whose informed consent could not be obtained.
6) In case that doctors judged inappropriate for the entry.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Mabuchi |
Organization
Mizonokuchi Hospital Teikyo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa 213-8507 JAPAN
TEL
044-844-3333
masatoshi.mabuchi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Mabuchi |
Organization
Mizonokuchi Hospital Teikyo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa 213-8507 JAPAN
TEL
044-844-3333
Homepage URL
masatoshi.mabuchi@gmail.com
Sponsor or person
Institute
Teikyo University Mizonokuchi Hospital Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
帝京大学医学部附属溝口病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028192
