UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control trial of secondary eradication therapies of Helicobacter pylori
Acronym	Secondary eradication therapies of Helicobacter
Scientific Title	Randomized control trial of secondary eradication therapies of Helicobacter pylori
Scientific Title:Acronym	Secondary eradication therapies of Helicobacter
Region	Japan

Condition
Condition	Gastroduodenal ulcer infected by Helicobacter pylori
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and the safety of Helicobacter pylori secondary therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of the Helicobacter pylori eradication on the bassis of the urea breath test result
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	rabeprazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
Interventions/Control_2	lansorazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
Interventions/Control_3	omeprazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who fills everything the following 1)Patients with gastric or duodenal ulcer 2)Patients of primary eradication failure 3)Patients infected by Helicobacter pylori, confirmed by bacterial culture test or rapid urease test or urea breath test 4)Patients of 20 years or more 5)Patients who gives written informed consent
Key exclusion criteria	1)Pregnant females 2)Lacting woman 3)Patients who has past history of allergy for the drugs used in this study 4)Patients who has coexisting severe disease 5)Patient whom examination doctor judged improper as testee
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin Maeda
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2010 Year 01 Month 21 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	Terminated
Date of protocol fixation	2008 Year 12 Month 04 Day
Date of IRB	2008 Year 12 Month 04 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 01 Month 21 Day
Last modified on	2020 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003729