UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022733 |
|---|---|
| Receipt number | R000026188 |
| Scientific Title | Endoscopic assessment based on the status of the Helicobacter pylori infection in patients with functional dyspepsia |
| Date of disclosure of the study information | 2016/06/14 |
| Last modified on | 2018/10/12 19:33:01 |
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Basic information
Public title
Endoscopic assessment based on the status of the Helicobacter pylori infection in patients with functional dyspepsia
Acronym
Endoscopic assessment associated with Helicobacter pylori in functional dyspepsia
Scientific Title
Endoscopic assessment based on the status of the Helicobacter pylori infection in patients with functional dyspepsia
Scientific Title:Acronym
Endoscopic assessment associated with Helicobacter pylori in functional dyspepsia
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the endoscopic findings in patients with functional dyspepsia (FD) based on the status of Helicobacter pylori infection.
Basic objectives2
Others
Basic objectives -Others
Detection of clinical characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic findings which are mainly included in Kyoto classification of gastritis
Key secondary outcomes
The strength of upper gastrointestinal symptoms; reflux and dyspeptic symptoms
The frequency of dyspeptic symptoms
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who underwent esophagogastroduodenoscopy and wrote the questionnaire and informed consent.
Key exclusion criteria
The patients with serious disease (cancer, heart, lung, liver, and kidney disease)
The patients with organic disease of upper gastrointestinal tract
The patients with no consent
The patients who underwent surgery of upper gastrointestinal tract
The patients who have no assement after the eradication of Helicobacter pylori and the time of eradication is unclear
Target sample size
870
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL
06-6645-3811
m2079981@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL
06-6645-3811
Homepage URL
m2079981@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intern Med. 2018 Sep 12. doi: 10.2169/internalmedicine.1325-18. [Epub ahead of print]
Management information
Registered date
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026188
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| Registered date | File name |
| Research case data | |
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