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Clinical Trials in China / NCT07179159
Recruiting Not applicable

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

NCT07179159 · tracked via the Priya Life Science China tracker
Sponsor
Yanqing Li
Phase
Not applicable
Started
2025-09-09
Last updated
2026-04-15

Condition(s) studied

HELICOBACTER PYLORI INFECTIONS

Investigational drug(s) / intervention(s)

14-day vonoprazan-amoxicillin dual therapy14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

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

Study summary

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18-70 years, male or female 2. Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue) 3. No prior Helicobacter pylori eradication therapy Exclusion Criteria: 1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Qilu Hospital of Shandong University Jinan China Not Yet Recruiting

More Yanqing Li trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07179159 on ClinicalTrials.gov ↗ ← All trials in China