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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016336
Receipt No. R000018956
Scientific Title Randomized Controlled Trial for H.pylori third line eradication therapy: PPI vs PCAB
Date of disclosure of the study information 2015/02/01
Last modified on 2020/01/30

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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/ctr_e/ctr_view.cgi?recptno=R000018956

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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