UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between refabutin-including 10 days and 14 days regimen
Title of the study (Brief title)	Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy
Region	Japan

Condition
Condition	H. pylori-positve patients after the 2nd line eradication failure
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of H. pylori eradication rates for 10 days or 14 days regimen with RBT, AMPC and PPI.
Basic objectives2	Others
Basic objectives -Others	MIC of RBT, AMPC, rpoB mutation
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The efficacy of H. pylori eradication
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	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	esomeprazole 80mg, q.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d. 10 days
Interventions/Control_2	esomeprazole 80mg, q.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d. 14 days
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	H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent
Key exclusion criteria	1. Patients with allergy for rifamycins 2. Patients with past histry of tuberculosis or nontuberculous mycobacterial infection 3. Patients with allergy for PPIs 4. Patients with allergy for penicillin 5. Patients with severe liver injury and/or severe renal damage 6. Pregnancy or possible pregnancy 7. Patients who are taking voriconazole 8. Patients with uveitis 9. Patients who were recognized as inappropriate for entry
Target sample size	170

Research contact person
Name of lead principal investigator	Hidekazu Suzuki
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Address	35 Shinanomachi, SHinjuku-ku, Tokyo
TEL	0353633914
Email	masaoka@z6.keio.jp

Public contact
Name of contact person	Hidekazu Suzuki
Organization	Keio University School of Medicine
Division name	Department of Internal Medicine
Address	35 Shinanomachi, SHinjuku-ku, Tokyo
TEL	070-6946-1119
Homepage URL	http://www.keio-med.jp/gastro/index.html
Email	masaoka@z6.keio.jp

Sponsor
Institute	Keio University 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	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 27 Day
Anticipated trial start date	2013 Year 10 Month 04 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 04 Day
Last modified on	2016 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000013976