Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
NCT ID: NCT07179159
Last Updated: 2025-09-17
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
NA
372 participants
INTERVENTIONAL
2025-09-09
2026-12-31
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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14-day vonoprazan-amoxicillin dual therapy
14-day vonoprazan-amoxicillin dual therapy
vonoprazan 20mg bid + amoxicillin 1000mg bid
14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy
14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy
vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid
Interventions
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14-day vonoprazan-amoxicillin dual therapy
vonoprazan 20mg bid + amoxicillin 1000mg bid
14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy
vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid
Eligibility Criteria
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Inclusion Criteria
2. Current Helicobacter pylori infection (positive 13C-urea breath test)
3. No prior Helicobacter pylori eradication therapy
Exclusion Criteria
2. Active gastrointestinal bleeding
3. History of upper gastrointestinal surgery
4. History of drug hypersensitivity
5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
6. Pregnant or lactating women
7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
8. Individuals unable or unwilling to provide informed consent
18 Years
70 Years
ALL
No
Sponsors
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Longkou People's Hospital
UNKNOWN
Qingdao Jimo People's Hospital
OTHER
Shandong University of Traditional Chinese Medicine
OTHER
Dezhou Hospital Qilu Hospital of Shandong University
OTHER
Zibo Maternal and Child Health Hospital
UNKNOWN
Guanxian People's Hospital
UNKNOWN
Yantai Zhifu Hospital
UNKNOWN
The 2nd People's Hospital of Dongying City
UNKNOWN
Qilu Hospital of Shandong University
OTHER
Yanqing Li
OTHER
Responsible Party
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Yanqing Li
Clinical Professor
Locations
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Qilu Hospital of Shandong University
Jinan, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202509
Identifier Type: -
Identifier Source: org_study_id
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