UMIN-CTR Clinical Trial

Basic information
Public title	PCAB-based H.pylori eradication study for patients with penicillin allergy
Acronym	PCAB-based H.pylori eradication study for patients with penicillin allergy (CAP-pen study)
Scientific Title	PCAB-based H.pylori eradication study for patients with penicillin allergy
Scientific Title:Acronym	PCAB-based H.pylori eradication study for patients with penicillin allergy (CAP-pen 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 P-CAB as first and second line H.pylori eradication for patients with penicillin allergy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The H.pylori eradication rate of Clarithromycin(CAM) + metronidazole(MNZ) + P-CAB (first line) and metronidazole(MNZ) + sitafloxacin(STFX) + P-CAB (second line) for patients with penicillin allergy.
Key secondary outcomes	To evaluate the safety of the two regimens for patients with penicillin allergy.

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Clarithromycin(CAM) + metronidazole(MNZ) + P-CAB (first line eradication) Metronidazole(MNZ) + sitafloxacin (STFX) + P-CAB (second line eradication)
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	Penicillin allergic patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Key exclusion criteria	Past history of taking second line H.pylori eradication therapy. 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	60

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	The Institute for Adult Diseases, Asahi Life Foundation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Certified Institutional Review Board
Address	Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel	045-370-7627
Email	ycu_crb@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	Published

Result
URL related to results and publications	https://jrct.niph.go.jp/latest-detail/jRCTs031180133
Number of participants that the trial has enrolled	60
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 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 26 Day
Last modified on	2020 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018955