drugset / Trial / NCT01906879

Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection

NCT01906879 ↗

Phase 4 Unknown 1620 enrolled National Taiwan University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown. Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days. Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy Testing for H. pylori infection Before First Line Ttreatment (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy

Timeline

Start
2013-06
Primary completion
2017-12
Completion
2017-12

Outcome

Met primary endpoint

paper 10-day bismuth quadruple therapy was superior to 14-day triple therapy (difference 6·7% [95% CI 2·7-10·7, p=0·001), but not 10-day concomitant therapy. PMID 27769562 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g —
Subject Bismuth subcitrate Unknown 300 mg —
Subject Clarithromycin Small molecule 500 mg —
Subject Lansoprazole Other / unclassified 30 mg —
Subject Metronidazole Small molecule 500 mg —
Subject Tetracycline Unknown 500 mg —