Status:
COMPLETED
Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Lead Sponsor:
Yongquan Shi
Conditions:
Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT06168084
Start Date
June 6 2023
End Date
August 30 2024
Last Update
July 3 2025
Active Locations (2)
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1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
2
Xijing Hosipital of Digestive Disease
Xi’an, Shanxi, China