drugset / Trial / NCT04348786

Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori

NCT04348786 ↗

Phase 4 Completed 78 enrolled Damascus Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.

Timeline

Start
2019-02-01
Primary completion
2020-08-30
Completion
2020-09-01

Outcome

Missed primary endpoint

paper Odds ratio with 95% confidence interval was 1.371 [0.454-4.146]. PMID 34218802 ↗

paper Levofloxacin concomitant therapy wasn't superior to doxycycline based quadruple therapy. PMID 34218802 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 1000 mg —
Subject Bismuth subsalicylate Small molecule 524 mg —
Subject Doxycycline Small molecule 100 mg —
Comparator Levofloxacin Small molecule 500 mg —
Background Esomeprazole Small molecule 20 mg —
Background tinidazole Small molecule 500 mg —