UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Third regimen for eradication of Helicobacter pylori resistant against first and sdcond regimen
Title of the study (Brief title)	Third regimen for eradication of Helicobacter pylori
Region	Japan

Condition
Condition	Helicobacter pylori infection
Classification by specialty	Medicine in general Gastroenterology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Third regimen for eradication of Helicobacter pylori resistant against first and second regimen
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	success for eradication of Helicobacter pylori
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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	Patients receive the regimen shown below. rabeprazole sodium 10 mg X 3 times/day+amoxicillin 500 mg X 3 times/day+ levofloxacin 500 mg once a day for 14 days.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a person who had first and second regimen for eradication of Helicobacter pylori and failed to eradicate Helicobacter pylori
Key exclusion criteria	The subjects who has allergic hypersensitivity against the drugs used in this study. The subjects who are judged to be inappropriate for this study by doctors conducting the study.
Target sample size	100

Research contact person
Name of lead principal investigator	Tetsuya tanigawa
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-4-3 Asahimachi, Abeno-ku Osaka City, Osaka 545-8585, Japan
TEL
Email

Public contact
Name of contact person
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address
TEL
Homepage URL
Email

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2012 Year 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 06 Day
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 08 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009845