UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027530 |
|---|---|
| Receipt number | R000031532 |
| Scientific Title | Investigation of pathophysiology of refractory peptic ulcers |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2021/12/05 19:58:40 |
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Basic information
Public title
Investigation of pathophysiology of refractory peptic ulcers
Acronym
pathophysiology of refractory peptic ulcers
Scientific Title
Investigation of pathophysiology of refractory peptic ulcers
Scientific Title:Acronym
pathophysiology of refractory peptic ulcers
Region
| Japan |
Condition
Condition
Refractory peptic ulcers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Despite improving cure rate of peptic ulcers are improving, some patients with peptic ulcer are still refractory to oral medical treatment and need surgical treatment. Aim of this study is to clarify pathophysiology of refractory peptic ulcers.
In this study, we check pH around peptic ulcer and other parts of stomach under endoscopy.
Basic objectives2
Others
Basic objectives -Others
Investigate of CYP2C19 gene polymorphism .
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
pH of upper gastrointestinal tract
Key secondary outcomes
gene polymorphism of CYP2C19
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with peptic ulcer who are refractory to medical treatment.
Patients who was planned esophagogastroduodenoscopy for following up
peptic ulcers.
Patients who understand aim of this study and can give informed consent.
Key exclusion criteria
Pregnant women
Patients who underwent chemotherapy and opioid treatment for cancer.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL
03-5363-3790
masaoka@keio.jp
Public contact
Name of contact person
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL
03-5363-3790
Homepage URL
masaoka@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2017 | Year | 05 | Month | 29 | 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
| 2017 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will ask patients to fulfill the questionnaire about symptom and
background of the patients.
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2021 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031532
| 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 |
