UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013060 |
|---|---|
| Receipt number | R000015165 |
| Scientific Title | The efficacy of the eradication of Helicobacter pylori for quality of life -Multicenter clinical study- |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2016/03/20 10:24:52 |
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Basic information
Public title
The efficacy of the eradication of Helicobacter pylori for quality of life
-Multicenter clinical study-
Acronym
Kagoshima pylori study
Scientific Title
The efficacy of the eradication of Helicobacter pylori for quality of life
-Multicenter clinical study-
Scientific Title:Acronym
Kagoshima pylori study
Region
| Japan |
Condition
Condition
Helicobacter infection without other orgnic disease
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since H. pylori infection as well as the digestive tract associated with blood disorders, allergic diseases etc. have been reported, the possibility that inhibit QOL potentially some influence on various fields. Upper abdominal symptoms caused by H. pylori infection if the cause of QOL inhibition, improvement of QOL by eradication can be expected of course. However, there are few reports that whether H. pylori eradication improved QOL of patients without upper abdominal symptoms. By performing the eradication of the patients with or without upper abdominal symptoms, we will be able to build a new evidence of H. pylori eradication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of quality of life before and after Helicbacter pylori eradication
Key secondary outcomes
1.Effect of full dose of administration of proton pump inhibitor for upper abdominal symptoms in before and after eradication of Helicobacter pylori.
2.Evaluation of the successful rate of eradication of Helicobacter pylori by preceding PPI administration before eradication.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For upper abdominal symptoms of Helicobacter pylori (H. pylori) infected patients, proton pump inhibitor (PPI) are administrated before the eradication of H. pylori. If the upper abdominal symptoms were not improved after the eradication therapy, further administration of PPI are done .
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are not administrated proton pump inhibitor (PPI) or administrated half dose of PPI.
Patients who are diagnosed atrophic gastritis with endoscopy.
Key exclusion criteria
Patients who are not diagnosed gastro-esophageal reflux disease (GERD) over the grade A of Los Angeles Classification, gastric ulcer, gastric cancer.
Patients who are not administrated non steroidal anti-inflammatory drugs (NSAIDs), major or minor tranquilizer, acotiamide every day.
Patients with history of gastrectomy.
Patients with severe renal or liver dysfunciton.
Patients with cancer.
Patients who have a history of failure of the first eradication of Helicobacter pylori.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Taguchi |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and Life-style related Disease
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5326
tag@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Taguchi |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and Life-style related Disease
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5326
Homepage URL
tag@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences, Digestive and Life-style related Disease
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Sciences, Digestive and Life-style related Disease
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 02 | Month | 03 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015165
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| Registered date | File name |
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| Registered date | File name |
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