drugset / Trial / NCT07537634

Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication

NCT07537634

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia. The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen. Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication. Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days. Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication. Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up. Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.

Timeline

Start
2026-04-15
Primary completion
2026-08-14
Completion
2026-08-14

Publications

  • Background Ahmed, E. U., Alam, R., Alam, F., Ghosh, C. K., Dey, S. K., Masud, H., Ahmed, D. S., Bhuiyan, M. M. R., Mia, Roy, P. K., and Raihan, A. S. M. A. (2009) 'Comparative study between Metronidazole, Amoxycilin, Omeprazole based therapy and Levofloxacin, Amoxycilin, Omeprazole based therapy for helicobacter pylori eradication in peptic ulcer disease', Journal of Chittagong Medical College Teachers Association, 20, pp. 29-32.
  • Background Abdelghani, Y. A., Moussa, M. M. (2023) Vonoprazan-Based Versus Esomeprazole-Based Triple Therapy for Helicobacter pylori: A Randomized Trial. Appli Microbiol Open Access. 9:258.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 20 mg
Subject Vonoprazan Other / unclassified 20 mg
Background Amoxicillin Other / unclassified 1 g
Background Levofloxacin Small molecule 500 mg