UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034140 |
|---|---|
| Receipt number | R000038357 |
| Scientific Title | Efficacy and safety of dual therapy containing vonopranzan and amoxicillin as first line Helicobacter pylori eradication: a randomized, non-inferiority trial |
| Date of disclosure of the study information | 2018/09/14 |
| Last modified on | 2020/03/01 19:28:47 |
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Basic information
Public title
Efficacy and safety of dual therapy containing vonopranzan and amoxicillin as first line Helicobacter pylori eradication: a randomized, non-inferiority trial
Acronym
Vonoprazan-based dual therapy for first line H. pylori eradication
Scientific Title
Efficacy and safety of dual therapy containing vonopranzan and amoxicillin as first line Helicobacter pylori eradication: a randomized, non-inferiority trial
Scientific Title:Acronym
Vonoprazan-based dual therapy for first line H. pylori eradication
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the efficacy and safety of dual therapy consisting of vonoprazan and amoxicillin comparing to standard triple therapy for first line H. pylori eradication treatment.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The primary outcome of this study is H. pylori eradication rates in the dual therapy and the standard triple therapy groups. Eradication success is evaluated at least 4 weeks after the treatment period using the urea breath test with success defined as a result of < 2.5 permil.
Key secondary outcomes
1. The rate of adverse events
2. The rate of treatment or intervention for adverse events
3. Number of defecation
4. Stool forms
5. Compliance of taking drugs
6. Eradication rate in patients who have H. pylori with antibiotic resistance
7. Oral and gut microbiota proliferation
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 considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonoprazan 20 mg twice/day and amoxicillin 750 mg twice/day for 7 days.
Interventions/Control_2
vonoprazan 20 mg twice/day, amoxicillin 750 mg twice/day, and clarithromycin 200 mg twice/day for 7 days.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients will be positive for H. pylori which confirmed through culture of biopsy specimens.
2) Aged 20-79 years
3) Performance Status (ECOG) 0, 1, or 2
4) Written informed consent
Key exclusion criteria
1) Allergy to vonoprazan, amoxicillin, or clarithromycin
2) A history of receiving H. pylori eradication therapy
3) A history of gastric surgery
4) Using PPI
5) Using antibiotics
6) Using steroid
7) Pregnancy
8) Breast-feeding
9) Lack of informed consent
10) Others
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Gotoda |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
takujigotoda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
Homepage URL
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nihon University Hospital
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
Tel
03-3293-1711
nuhosp.rinri@nihon-u.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
日本大学病院（東京都）、由利組合総合病院（秋田県）、大崎市民病院（宮城県）、仙台市立病院（宮城県）、深谷赤十字病院（埼玉県）、山梨県厚生連健康管理センター（山梨県）、秩父市立病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
335
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
| 2018 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 29 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038357
