Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

NCT06168084 | Completed Phase 4

• 1 other identifier: KY20232236-F-2
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 2

Brief Summary

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

Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication

  The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication

  28 days after treatment

Secondary Outcomes (2)

• symptoms effective rates

  14 days of treatment, and 28 days after treatment

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (2)

Vonorazon and amoxicillin dual therapy

EXPERIMENTAL

Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days

Drug: Vonoprazan; Drug: amoxicillin

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Drug: Bismuth; Drug: Esomeprazole; Drug: Tetracycline; Drug: Furazolidone

Interventions

Vonoprazan DRUG

Vonoprazan and amoxicillin dual therapy:given for 14 days at a dose of vonoprazan 20mg 1 tablet BID plus amoxicillin 500 mg 2 capsules TID

Vonorazon and amoxicillin dual therapy

amoxicillin DRUG

Vonoprazan and amoxicillin dual therapy:given for 14 days at a dose of vonoprazan 20mg 1 tablet BID plus amoxicillin 500 mg 2 capsules TID

Vonorazon and amoxicillin dual therapy

Bismuth DRUG

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Bismuth-containing quadruple therapy

Esomeprazole DRUG

Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablets BID plus bismuth 110 mg 2 capsules BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Bismuth-containing quadruple therapy

Tetracycline DRUG

Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID#esomeprazole 20 mg 2 tablets BID and bismuth 110 mg 2 capsules BID

Bismuth-containing quadruple therapy

Furazolidone DRUG

Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID#esomeprazole 20 mg 2 tablets BID and bismuth 110 mg 2 capsules BID

Bismuth-containing quadruple therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
• \. Contraindications to study drugs. 3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
• \. 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).
• \. 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).
• \. Mental disorder. 13. Enrolled in other clinical trials in the past 3 months. 14. Refuse to sign informed consent.

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (2)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Xijing Hosipital of Digestive Disease

Xi’an, Shanxi, China

Location

Related Publications (1)

• Zhang 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 DERIVED

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Bismuth; Esomeprazole; Tetracycline; Furazolidone

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Furans

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 13, 2023
• Study Start: June 6, 2023
• Primary Completion: May 30, 2024
• Study Completion: August 30, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)