UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014366 |
|---|---|
| Receipt number | R000016713 |
| Scientific Title | Evaluation of the efficasy of H. pylori eradication therapies using different PPI. |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/10/16 15:51:00 |
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Basic information
Public title
Evaluation of the efficasy of H. pylori eradication therapies using different PPI.
Acronym
H. pylori eradication rate using different PPI.
Scientific Title
Evaluation of the efficasy of H. pylori eradication therapies using different PPI.
Scientific Title:Acronym
H. pylori eradication rate using different PPI.
Region
| Japan |
Condition
Condition
gastritis caused by H. pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the factors, which affect the results of eradication therapy using 2 PPIs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
erdication rate
Key secondary outcomes
effects on dyspeptic symptoms
adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole
Interventions/Control_2
esomeprazole
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are infected with H. pylori and underwent upper GI endoscopy.
Key exclusion criteria
gastric cancer
open peptic ulcers
allergy to drugs
past history of eradication therapy
past history of gastric surgery
administration of PPI or antibiotics
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsaku Fukuda |
Organization
Hirosaki University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
5 Zaifu-cho, Hirosaki
TEL
0172-39-5053
sfukuda@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Shimoyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
5 Zaifu-cho, Hirosaki
TEL
0172-39-5053
Homepage URL
tsimo-hki@umin.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sawada Clinic, Sasaki Clinic, Shinjo Clinic, Chiba Clinic, Komai Clinic, Tsugaru Citizen Clinic
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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2169/internalmedicine.56.7823
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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016713
| 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 |
