Clinical trial · Interventional
Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims at evaluating efficacy and safety of Vonorazon and amoxicillin dual therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Vonorazon and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amoxicillin | Drug | — | UNRESOLVED |
| Bismuth | Drug | — | UNRESOLVED |
| Esomeprazole | Drug | — | UNRESOLVED |
| Furazolidone | Drug | — | UNRESOLVED |
| Tetracycline | Drug | — | UNRESOLVED |
| Vonoprazan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vonorazon and amoxicillin dual therapy
- description
- Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days
- interventionNames
- Drug: Vonoprazan
- Drug: amoxicillin
- type
- ACTIVE_COMPARATOR
- label
- Bismuth-containing quadruple therapy
- description
- Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Bismuth
- Drug: Esomeprazole
- Drug: Tetracycline
- Drug: Furazolidone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age between 18\~70, both gender. 2. Patients who had failed H.pylori eradication therapies . 3. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. Exclusion Criteria: * 1\. Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori. 2\. Contraindications to study drugs. 3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 4\. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening). 5\. Pregnant or lactating women. 6. Underwent upper gastrointestinal Surgery. 7. Dysphagia. 8. Evidence of bleeding or iron efficiency anemia. 9. A history of malignancy. 10. Drug or alcohol abuse history in the past 1 year. 11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12\. Mental disorder. 13. Enrolled in other clinical trials in the past 3 months. 14. Refuse to sign informed consent.
References
Publications (1)
- DERIVEDZhang J, Wang X, Song S, Zhu X, Lv T, Wang L, Lei L, Wang Y, Lei Y, Wang Y, Zhu X, Zhang L, Chen M, Shi Y. Efficacy and Safety of Vonoprazan and High-Dose Amoxicillin Dual Therapy for Rescue Treatment of Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial. United European Gastroenterol J. 2025 Oct;13(8):1541-1549. doi: 10.1002/ueg2.70070. Epub 2025 Jun 21. PMID 40543051