UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of non-bismuth concomitant and standard triple therapies as a first-line treatment option for Helicobacter pylori in Japan
Acronym	Concomitant therapies for Helicobacter pylori first line eradication
Scientific Title	Comparison of non-bismuth concomitant and standard triple therapies as a first-line treatment option for Helicobacter pylori in Japan
Scientific Title:Acronym	Concomitant therapies for Helicobacter pylori first line eradication
Region	Japan

Condition
Condition	Helicobacter pylori infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparative analysis of efficacy and safety in eradication therapy as 1st line, PPI+AMPC+CAM+MNZ versus PPI+AMPC+CAM
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of the eradication rate of the two regimens, PPI+AMPC +CAM+MNZ versus PPI+AMPC+CAM for first line
Key secondary outcomes	Comparison of the safety of the two regimens, PPI+AMPC +CAM+MNZ versus PPI+AMPC+CAM for first line

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	PPI+AMPC +CAM+MNZ
Interventions/Control_2	PPI+AMPC+CAM
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with H.pylori infection who want to take eradication therapy. Patients who give a written informed consent.
Key exclusion criteria	Patients were excluded from the study if they were younger than 20 years or older than 80 years, were allergic to the drugs used in this therapy. Patients who are disqualified for the study by physicians.
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Takagi
Organization	Tokai University School of Medicine
Division name	General Internal Medicine
Zip code
Address	143 Shimokasuya Isehara, Kanagawa, 259-1193 Japan
TEL	0463-93-1121
Email	takagia@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takayoshi Suzuki
Organization	Tokai University School of Medicine
Division name	Division of Gastroenterology & Hepatology
Zip code
Address	143 Shimokasuya Isehara Kanagawa Japan 259-1193
TEL	0463-93-1121
Homepage URL
Email	takayosh@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Tokai University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Medical University Hamamatsu University School of Medicine
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	東海大学付属病院/Tokai　University School　of Medicine（神奈川県） 東京医科大学/ Tokyo Medical University（東京都） 浜松医科大学/ Hamamatsu University School of Medicine（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 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	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 05 Month 11 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 02 Day
Last modified on	2020 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021043