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Efficacy Comparison of Vonoprazan Combined with Centralized Procurement versus Non-Centralized Procurement Amoxicillin Dual Therapy in Eradicating Helicobacter pylori: A Multicenter, Non-Inferiority, Randomized Controlled Study.

Efficacy Comparison of Vonoprazan Combined with Centralized Procurement versus Non-Centralized Procurement Amoxicillin Dual Therapy in Eradicating Helicobacter pylori: A Multicenter, Non-Inferiority, Randomized Controlled Study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099087
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-03-22
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Helicobacter pylori infection

Interventions

VHKA:vonoprazan 20mg bid,amoxicillin(Hunan Kelun) 1g tid for 14 days
VHLA:vonoprazan 20mg bid,amoxicillin(Zhuhai Federation) 1g tid for 14 days

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Age: 17~70 years old, male or female. 2 Confirmed Helicobacter pylori infection (positive 13C/14C-urea breath test). 3 People who have been eradicated for the first time (who have received eradication therapy for HP infection for the first time) and people who have been eradicated for the second time (who have continued treatment after the failure of eradication therapy for HP infection for the first time). 4 No penicillin allergy. 5 The study subject voluntarily joins this trial, understands and agrees to follow the requirements of the study. Informed consent signed by the patient or his/her legal representative.

Exclusion criteria

Exclusion criteria: 1 Use of drugs that may affect the results of the study within four weeks before treatment (including PPIs, potassium competitive acid blockers, antibiotics, H2 receptor antagonists, bismuth agents, probiotic preparations, traditional Chinese medicine, etc.). 2 Individuals who are allergic to amoxicillin or vornoraxen or have contraindications. 3 Presence of other serious diseases that affect the evaluation of this study. (e.g., severe systemic disease, liver and kidney dysfunction, malignant gastrointestinal tumors) 4 Previous upper gastrointestinal surgery. 5 Concurrent use of non-steroidal anti-inflammatory drugs, adrenocorticosteroids, anticoagulants, and alcoholism during treatment. 6 Pregnant, lactating, or planning to become pregnant. 7 Difficulty in completing follow-up or presence of other factors affecting adherence 8 Have participated in other clinical studies within 3 months of this trial or are participating in other clinical studies. 9 Patients with previous failed Helicobacter pylori eradication regimen including amoxicillin.

Design outcomes

Primary

MeasureTime frame
Comparison of helicobacter pylori eradication rate;Cost-effectiveness analysis;

Secondary

MeasureTime frame
Comparison of incidence of adverse reactions;Gastrointestinal Symptom Improvement Rate;Comparison of compliance;Factors influencing eradication rate;Changes in Gut Microbiota;

Countries

China

Contacts

Public ContactDe-Kui Zhang

Lanzhou University Second Hospital

sczdk1972@163.com+86 139 0931 8616

Outcome results

None listed

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