drugset / Trial / NCT04531059

Rescue Therapy for Helicobacter Pylori Eradication Treatment

NCT04531059

Phase 4 Completed 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 minocycline.

Timeline

Start
2020-10-15
Primary completion
2022-12-20
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Minocycline Small molecule 100 mg
Comparator Tetracycline Unknown 500 mg
Background Bismuth Potassium Citrate Unknown 600 mg
Background Esomeprazole Small molecule 20 mg
Background Metronidazole Small molecule 400 mg