Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismu… (NCT04678492) | Clinical Trial Compass
CompletedPhase 4
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
China658 participantsStarted 2020-12-20
Plain-language 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，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).