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A randomized, open clinical study to evaluate the efficacy and safety of vonoprazan combined with amoxicillin in the eradication of Helicobacter pylori

A randomized, open clinical study to evaluate the efficacy and safety of vonoprazan combined with amoxicillin in the eradication of Helicobacter pylori

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075479
Enrollment
Unknown
Registered
2023-09-06
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Helicobacter pylori

Interventions

1:Amoxicillin 1g/ twice/day + vonoprazan 20mg/ twice/day (14 days)
2:Amoxicillin 750mg/ time 4 times/day + vonoprazan 20mg/ time 2 times/day (14 days)
3:Amoxicillin 750mg/ time 4 times/day + Rabeprazole 20mg/ time 2 times/day (14 days)

Sponsors

Guangzhou First People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old; 2. First eradication of HP treatment patients; 3.13C urea breath test proved positive for HP infection; 4. Agree to undergo gastroscopy and gastric mucosa biopsy, and carry out drug sensitivity test on the specimen.

Exclusion criteria

Exclusion criteria: 1. Amoxicillin allergy; 2. Amoxicillin resistance; 3. Patients with Zollinger-Ellison syndrome or gastric cancer or upper gastrointestinal bleeding or acute peptic ulcer; 4. Patients with a history of heart, kidney and liver disease, surgical history or pregnancy; 5. Used acid suppressants or antibiotics in the past month; 6. Reluctance to participate in the study.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Incidence of adverse reactions;

Countries

China

Contacts

Public ContactLin Jia

Guangzhou First People’s Hospital

13925012853@139.c0m+86 139 2501 2853

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026