Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicob… (NCT07068607) | Clinical Trial Compass
RecruitingPhase 4
Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
China400 participantsStarted 2025-04-01
Plain-language summary
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Aged 18 - 70 years, regardless of gender;
✓. Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
✓. For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.
Exclusion criteria
✕. Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
✕. Patients with contraindications to the study drug or who are allergic to the study drug;
✕. Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
✕. Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening);