UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021604 |
|---|---|
| Receipt number | 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 | 2021/10/01 14:41:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | 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
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
ssue@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
Yokohama City University Ethics Committee
Address
Fukuura3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel
045-370-7627
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
| 2016 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/28566587/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/28566587/
Number of participants that the trial has enrolled
1593
Results
The first-line eradication rates (ER) in the ITT and PP analyses were 84.9% and 86.4%, respectively, for VAC and 78.8% and 79.4%, respectively, for PAC. The ER of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses (p=0.0013). In the second-line ITT and PP analyses VAM achieved ERs of 80.5% and 82.4%, respectively, while PAM achieved ERs of 81.5% and 82.1%, respectively. No significant differences were observed in the ITT (p=0.89) or PP (p=1.0) analyses.
Results date posted
| 2021 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics for first line VAC were 64.3 years (age) and male 54.4%, and for first line PAC were 64.5 years and male 56.9%.
Baseline characteristics for second line VAM were 67.5 years and male 57.8%, and for the second line PAM were 63.9 year and male 45.5%.
Participant flow
1770 screened for eligibility, and the 1231 for first line eradication and the 362 for second line eradication were recruited.
Adverse events
PAC was associated with higher AEQ scores than VAC for diarrhea, nausea, headache, and general malaise.
Outcome measures
The first-line eradication rates (ER) in the ITT and PP analyses were 84.9% and 86.4%, respectively, for VAC and 78.8% and 79.4%, respectively, for PAC. The ER of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses (p=0.0013). In the second-line ITT and PP analyses VAM achieved ERs of 80.5% and 82.4%, respectively, while PAM achieved ERs of 81.5% and 82.1%, respectively. No significant differences were observed in the ITT (p=0.89) or PP (p=1.0) analyses.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 24 | Day |
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
| 2021 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.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 |
