UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033795 |
|---|---|
| Receipt number | R000038553 |
| Scientific Title | Study on the efficacy of l-menthol solution for esophageal peristalsis |
| Date of disclosure of the study information | 2018/08/17 |
| Last modified on | 2021/08/19 12:54:59 |
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Basic information
Public title
Study on the efficacy of l-menthol solution for esophageal peristalsis
Acronym
Efficacy of l-menthol solution for esophageal peristalsis
Scientific Title
Study on the efficacy of l-menthol solution for esophageal peristalsis
Scientific Title:Acronym
Efficacy of l-menthol solution for esophageal peristalsis
Region
| Japan |
Condition
Condition
esophageal motility disorder, esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of l-menthol solution on esophageal peristalsis
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in peristalsis of the esophagus of high resolution manometry (HRM) after spraying l-menthol solution
Key secondary outcomes
Efficacy of endoscopic submucosal dissection (ESD) on superficial esophageal cancer by spraying l-menthol solution
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
spraying l-menthol solution
Interventions/Control_2
placebo
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
patient of esophageal cancer
Key exclusion criteria
Under 20 years old, patients with serious heart disease, kidney disease,liver disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tatsuta |
Organization
Hirosaki University School of Medicine
Division name
Department of gastroenterology
Zip code
036-8562
Address
5 Zaifucho Hirosaki city, Aomori, Japan
TEL
0172-33-5111
tatsuta.t@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tatsuta |
Organization
Hirosaki University School of Medicine
Division name
Department of gastroenterology
Zip code
036-8562
Address
5 Zaifucho Hirosaki city, Aomori, Japan
TEL
0172-33-5111
Homepage URL
tatsuta.t@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of gastroenterology
Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of gastroenterology
Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hirosaki University School of Medicine and Hospital
Address
5 Zaifucho Hirosaki city, Aomori, Japan
Tel
0172-33-5111
cksenta@hirosaki-u.ac.jp
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
| 2018 | Year | 08 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038553
