UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficasy of H. pylori eradication therapies using different PPI.
Title of the study (Brief title)	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	Shinsaku Fukuda
Organization	Hirosaki University Graduate School of Medicine
Division name	Gastroenterology
Address	5 Zaifu-cho, Hirosaki
TEL	0172-39-5053
Email	sfukuda@cc.hirosaki-u.ac.jp

Public contact
Name of contact person	Tadashi Shimoyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.2169/internalmedicine.56.7823
Results
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/icdr_e/ctr_view.cgi?recptno=R000016713