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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021604
Receipt No. R000024888
Scientific Title Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy
Date of disclosure of the study information 2016/03/25
Last modified on 2016/06/29

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Basic information
Public title Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy
Acronym Prospective multicenter cohort study of H. pylori eradication
Scientific Title Prospective multicenter cohort study to evaluate the efficacy and safety of Helicobacter pylori eradication therapy
Scientific Title:Acronym Prospective multicenter cohort study of 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 compare the efficacy and safety of H. pylori eradication therapy between P-CAB (vonoprazan) and PPI based, as a prospective multicenter cohort study and retrospective study.
And to evaluate the factors affecting post-eradication gastric carcinogenesis and reinfection of H. pylori by a long-term follow-up of the cohort.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Comparison of eradication rate by
1) Regimens (P-CAB/AMPC/CAM 1week, PPI/AMPC/CAM 1week, P-CAB/AMPC/MNZ 1week, P-CAB/AMPC/MNZ 1week, etc.)
2) Eradication number of times (first line, second line, etc.)
3) prospective, retrospective
4) Antibiotic-resistance of H. pylori (CAM resistance, MNZ resistance, etc.)
5) Another factors that affect the eradication (smoking etc.).
Success of eradication was assessed by urea breath test or H. pylori stool antigen test more than 4 weeks after treatment
Key secondary outcomes 1)Safety evaluated by side effects questionnaire filled by patients during therapy
2)Rate of post-eradication gastric carcinogenesis, reinfection of H. pylori, and factors affecting them

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vonoprazan 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg or 400mg bid
1week
Interventions/Control_2 Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg,or Esomeprazole 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg or 400mg bid
1week
Interventions/Control_3 Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
1week
Interventions/Control_4 Lansoprazole 30mg, Rabeprazole 10mg, Omeprazole 20mg,or Esomeprazole 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
1week
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 <Prospective study>
A patient with H.pylori infection.
A patient who give a written informed consent.

<Retrospective study>
A patient who performed H. pylori eradication therapy in participation institutes of this study after November 2009.
A patient who give informed consent as opt-out in each participation institutes of this study.
Key exclusion criteria <Prospective study>
A patient participating in UMIN000016335(PCAB-based H.pylori eradication study for patients with penicillin allergy), UMIN000016336(PCAB-based H.pylori third line eradication study), UMIN000016337(PCAB-based H.pylori first line eradication study), or UMIN000019628(Efficacy of UBT after PCAB-based H.pylori eradication)
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.

<Retrospective study>
A patient participating in UMIN000016335(PCAB-based H.pylori eradication study for patients with penicillin allergy), UMIN000016336(PCAB-based H.pylori third line eradication study), UMIN000016337(PCAB-based H.pylori first line eradication study), or UMIN000019628(Efficacy of UBT after PCAB-based H.pylori eradication)
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Maeda
Organization Yokohama City University Hospital
Division name Gastroenterology
Zip code
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
Middle name
Last name Soichiro Sue
Organization Yokohama City University Hospital
Division name Gastroenterology
Zip code
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 Yokohama Gastro Intestinal Study Group(YGISG):
Yokohama City University Medical Center, Yokohama Minami Kyousai Hospital, Saiseikai Yokohamashi Nanbu Hospital, Fujisawa City Hospital, Kanagawa Cancer Center, Yokohama Hodogaya Central Hospital, Yokohama Ekisaikai Hospital, Kanagawa Prefectual Ashigarakami Hospital, Yokosuka City Hospital, Japanese Red Cross Hadano Hospital, Fujisawa Shounandai Hospital
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 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
2016 Year 03 Month 25 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 05 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 26 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
2016 Year 03 Month 24 Day
Last modified on
2016 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024888

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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