UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of fasle negative rates of urea breath test in patients after PCAB-based eradication therapy for clarithromycin resistance H.pylori
Acronym	Efficacy of UBT after PCAB-based H.pylori eradication
Scientific Title	Comparison of fasle negative rates of urea breath test in patients after PCAB-based eradication therapy for clarithromycin resistance H.pylori
Scientific Title:Acronym	Efficacy of UBT after PCAB-based H.pylori eradication
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of urea breath test in patients after PCAB-based eradication therapy for clarithromycin resistance H.pylori.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	False-negative rate of urea breath test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	urea breath test, stool H.pylori antigen test
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with clarythromycin resistance H.pylori infection who take eradication treatment. Patients who test efficacy of H.pylori eradication therapy by urea breath test. Patients who give a written informed consent.
Key exclusion criteria	Pregnancy or lactation. Past history of allergy for the drugs used in H.pylori eradication. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shin Middle name Last name Maeda
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code	236-0004
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-261-5656
Email	ssue@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Soichiro Middle name Last name Sue
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code	236-0004
Address	Fukuura3-9, Kanazawa, Yokohama, Kanazawa, Japan
TEL	045-261-5656
Homepage URL
Email	ssue@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University(Basic research expenditures)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Ethics Committee
Address	Fukuura3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel	045-3707627
Email	rinri@yokohama-cu.ac.jp

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	横浜市立大学附属病院（神奈川県）Yokohama City University Hospital(kanagawa)

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 05 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	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 04 Day
Last modified on	2020 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022678