drugset / Trial / NCT05874570

Doxycycline for Helicobacter Pylori Rescue Treatment

NCT05874570 ↗

Phase 4 Recruiting 368 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by doxycycline.

Timeline

Start
2023-06-20
Primary completion
2025-10-10
Completion
2025-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule 100 mg —
Comparator Tetracycline Unknown 500 mg —
Background Bismuth Potassium Citrate Unknown 110 mg —
Background Esomeprazole Small molecule 20 mg —
Background Metronidazole Small molecule 400 mg —