Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
Efficacy of Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2023
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2023
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2026
CompletedFebruary 14, 2023
February 1, 2023
2 years
February 3, 2023
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
Six weeks after completion of therapy
Secondary Outcomes (2)
Rate of adverse effects
Within 7 days after completion of therapy
Compliance rate
Within 7 days after completion of therapy
Study Arms (2)
Vonoprazan-containing Triple Therapy
ACTIVE COMPARATORVonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Empiric Bismuth Quadruple Therapy
EXPERIMENTALEsomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Interventions
Antibiotics for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Eligibility Criteria
You may qualify if:
- Participants with non-ulcer functional dyspepsia or peptic ulcer disease
- 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
You may not qualify if:
- Less than 18 years old
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingjie Ji, M.D.
Shanghai East Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 14, 2023
Study Start
February 6, 2023
Primary Completion
February 6, 2025
Study Completion
February 6, 2026
Last Updated
February 14, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share