UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Controlled Trial for H.pylori third line eradication therapy: PPI vs PCAB
Acronym	PCAB-based H.pylori third line eradication study (CAP-3 study)
Scientific Title	Randomized Controlled Trial for H.pylori third line eradication therapy: PPI vs PCAB
Scientific Title:Acronym	PCAB-based H.pylori third line eradication study (CAP-3 study)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of PCAB for third line H.pylori eradication.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of third line H.pylori eradication rate of the two regimens, sitafloxacin(STFX) +amoxicillin(AMPC)+ P-CAB vs sitafloxacin(STFX) +amoxicillin(AMPC)+ PPI
Key secondary outcomes	Comparison of Safety of the two regimens, sitafloxacin(STFX) +amoxicillin(AMPC)+ P-CAB vs sitafloxacin(STFX) +amoxicillin(AMPC)+ PPI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	sitafloxacin(STFX) +amoxicillin(AMPC)+ P-CAB
Interventions/Control_2	sitafloxacin(STFX) +amoxicillin(AMPC)+ PPI
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	First line eradication(PPI+AMPC+CAM) and second line eradication(PPI+AMPC+MNZ) failure patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Key exclusion criteria	Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians.
Target sample size	126

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	smaeda@med.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, Kanagawa, 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	Fukuura 3-9, Kanazawa, Yokohama City, Kanagawa
Tel	045-370-7627
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	横浜市立大学付属病院（神奈川県）Yokohama City University Hospital (kanagawa)

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/30151994
Number of participants that the trial has enrolled	87
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 01 Month 15 Day
Date of IRB	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 28 Day
Date of closure to data entry	2019 Year 03 Month 29 Day
Date trial data considered complete	2019 Year 03 Month 29 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 01 Month 26 Day
Last modified on	2020 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018956