The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
Xijing hospital
Xi'an, Shaanxi, China
Helicobacter pylori eradication rate
The primary end point of this study is H.pylori eradication,established by negative urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament
Time frame: 28 days after treatment
Incidence of Treatment-Emergent Adverse Events (Safety)
Newly occurring drug-related symptoms during the treatment process
Time frame: 14 days of treatment
Rate of participants with good medication compliance (Compliance)
Taking more than 80% of medication is defined as good compliance
Time frame: 14 days of treatment
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