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

NCT ID: NCT06168084

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 688 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2024-08-30

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.

Detailed Description

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.

Conditions

Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vonorazon and amoxicillin dual therapy

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

Group Type: EXPERIMENTAL

Vonoprazan

Intervention Type: 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

amoxicillin

Intervention Type: 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

Bismuth-containing quadruple therapy

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

Group Type: ACTIVE_COMPARATOR

Bismuth

Intervention Type: 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

Esomeprazole

Intervention Type: 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

Tetracycline

Intervention Type: 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

Furazolidone

Intervention Type: 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

Interventions

Vonoprazan

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

Intervention Type: DRUG

amoxicillin

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

Intervention Type: DRUG

Bismuth

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

Intervention Type: DRUG

Esomeprazole

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

Intervention Type: DRUG

Tetracycline

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

Intervention Type: DRUG

Furazolidone

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yongquan Shi

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Xijing Hosipital of Digestive Disease

Xi’an, Shanxi, China

Countries

China

References

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 Jun 21. doi: 10.1002/ueg2.70070. Online ahead of print.

Reference Type: DERIVED

PMID: 40543051 (View on PubMed)

Other Identifiers

KY20232236-F-2

Identifier Type: -

Identifier Source: org_study_id