UMIN-CTR Clinical Trial

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
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Interventions/Control_6
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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
Email	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
Email	masaoka@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031532