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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07179159

Enrollment

372

Registered

2025-09-17

Start date

2025-09-09

Completion date

2026-12-31

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HELICOBACTER PYLORI INFECTIONS

Brief 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.

Interventions

DRUG14-day vonoprazan-amoxicillin dual therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid

DRUG14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid

DRUG14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
eradication rate	6 weeks after treatment

Secondary

Measure	Time frame	Description
adverse events	immediately after a 2-week treatment	—
compliance	immediately after a 2-week treatment	Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients.

Countries

China

Contacts

CONTACTYueyue Li

lyynqj@126.com+8618560089751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026