Status:
COMPLETED
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Gastritis
Dyspepsia
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，...
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
- Patients who had failed H.pylori eradication therapies before.
- Age between 18\~70, both gender.
- Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months.
- 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
- Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
- Contraindications to study drugs.
- 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.
- Underwent upper gastrointestinal Surgery.
- Patients with moderate or severe atypical hyperplasia or high-grade intraepithelial neoplasia.
- have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- a person with a mental disorder.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Key Trial Info
Start Date :
December 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT04678492
Start Date
December 20 2020
End Date
December 20 2021
Last Update
January 31 2023
Active Locations (1)
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1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032