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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034140
Receipt No. 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 2019/09/06

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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
Email 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
Email s.sho.salubriter.mail@gmail.com

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
Institute
Department

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
Email 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 Unpublished

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
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038357

Research Plan
Registered date File name
2019/09/27 Protocol_DualTherapy_final.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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