CompletedNot Applicable

Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study

China400 participantsStarted 2024-03-31

Plain-language summary

To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Age 18-65 years old;
✓. Patients who have had a positive 13C or 14C breath test and have not received Helicobacter pylori eradication therapy before, or 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, furazolidone, Tegoprazan, etc.);
✕. Patients with active peptic ulcer disease;
✕. Patients who have received Helicobacter pylori eradication therapy within half a year;
✕. Use of antibiotics, bismuth, histamine H2 receptor antagonists or PPIs for 4 weeks before starting study treatment;
✕. use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants;
✕. History of esophageal or gastric surgery;
✕. Pregnant or lactating women;
✕. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;

What they're measuring

Helicobacter pylori eradication rate

Timeframe: 4-6 weeks after the end of the last dose

Trial details

NCT IDNCT06340334

SponsorNanjing First Hospital, Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials