Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for… (NCT06412588) | Clinical Trial Compass
CompletedNot Applicable
Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
China579 participantsStarted 2024-06-15
Plain-language summary
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18-65 years old;
✓. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
✓. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
✓. Voluntarily join this trial and sign the informed consent form.
Exclusion criteria
✕. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
✕. Patients with confirmed active peptic ulcer;
✕. Patients who have received Helicobacter pylori eradication therapy within half a year;
✕. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
✕. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
What they're measuring
1
HP eradication rate
Timeframe: 4-6 weeks after the end of the last dose
Trial details
NCT IDNCT06412588
SponsorNanjing First Hospital, Nanjing Medical University