Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
NCT ID: NCT05726734
Last Updated: 2023-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2023-02-06
2026-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vonoprazan-containing Triple Therapy
Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Vonoprazan
potassium-competitive acid blocker
Amoxicillin, Metronidazole
Antibiotics for H. pylori eradication
Empiric Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Amoxicillin, Metronidazole
Antibiotics for H. pylori eradication
Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Esomeprazole
Proton pump inhibitor
Interventions
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Vonoprazan
potassium-competitive acid blocker
Amoxicillin, Metronidazole
Antibiotics for H. pylori eradication
Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Esomeprazole
Proton pump inhibitor
Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with no previous treatment experience
Exclusion Criteria
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
18 Years
70 Years
ALL
No
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Yingjie Ji
Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital
Principal Investigators
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Yingjie Ji, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022150
Identifier Type: -
Identifier Source: org_study_id
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