UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040951 |
|---|---|
| Receipt number | R000046095 |
| Scientific Title | surveys of the reality of Helicobacter pylori-negative and non-steroidal anti-inflammatory drugs-negative idiopathic peptic ulcers |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2023/01/04 21:19:38 |
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Basic information
Public title
surveys of the reality of idiopathic peptic ulcers
Acronym
surveys of the reality of idiopathic peptic ulcers
Scientific Title
surveys of the reality of Helicobacter pylori-negative and non-steroidal anti-inflammatory drugs-negative idiopathic peptic ulcers
Scientific Title:Acronym
surveys of the reality of Helicobacter pylori-negative and non-steroidal anti-inflammatory drugs-negative idiopathic peptic ulcers
Region
| Japan |
Condition
Condition
idiopathic peptic ulcers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of pathophysiology and etiology of non-Helicobacter pylori/non-NSAIDs-induced peptic ulcers
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence rate and cure rate of idiopathic peptic ulcers
Key secondary outcomes
characteristic of idiopathic peptic ulcers
(Preferential location,Comorbidities,risk of drug-induced peptic ulcers without NSAIDs and steroids)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are not Helicobacter pylori infected (after successful eradication or uninfected state) at the time of esophagogastroduodenoscopy.
2) Patients who have not taken NSAIDs(including COX2 selective inhibitor, gel preparation, poultice preparation, low-dose aspirin) at the time of esophagogastroduodenoscopy.
Key exclusion criteria
(1) Patients who are taking steroids
(2) Patients who take NSAIDs at least once a week
(3) Helicobacter pylori positive patients or untested patients
(4) Patients with history of surgical operation on esophagus, stomach, and duodenum
(5) Ulcers associated with malignant diseases (including metastatic lesions and lymphoma)
(6) Ulcer after endoscopic treatment
(7) Patients who refuse to participate in this study
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
569-0801
Address
2-7, Daigaku-machi, Takatsuki-city
TEL
+81-72-683-1221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Kawaguchi |
Organization
Osaka Medical Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
569-0801
Address
2-7, Daigaku-machi, Takatsuki-city
TEL
+81-72-683-1221
Homepage URL
taisyatyou3tyoume@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
The Japanese gastroenterological Association
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
Osaka Medical College Research ethics committee
Address
2-7, Daigaku-machi, Takatsuki-city
Tel
0726831221
rinri@ompu.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
| 2020 | Year | 06 | Month | 30 | 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
309
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
| 2019 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective, multi-center, prospective observational study.
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
