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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014366
Receipt No. 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

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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
Email 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
Email tsimo-hki@umin.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016713

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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