The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
330
Drug combinations for dual regimens:vonoprazan+amoxicillin
Duration of eradication regimen: 7-day
Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGEradication rate
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time frame: Six weeks after treatment
Rate of adverse reactions
Drug-related adverse reactions needs to be recorded after treatment
Time frame: Immediately after treatment
Patient compliance
The number of missed and overdosed doses of medication needs to be completed after treatment.
Time frame: Immediately after treatment
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Duration of eradication regimen: 10-day
Duration of eradication regimen: 14-day