drugset / Trial / NCT01163435

Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication

NCT01163435 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country. The aims of this study are: 1. to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication; 2. to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy as rescue regimen in H. pylori eradication; 3. to compare the patient adherence and adverse effects of these treatment regimens; 4. to investigate factors that may influence H. pylori eradication by these treatment regimens; 5. to investigate and analyze the prevalence and trend of antibiotic resistance.

Timeline

Start
2010-08
Primary completion
2013-07
Completion
2013-10

Outcome

Met primary endpoint

paper CONCLUSIONS: HDDT is superior to standard regimens as empirical first-line or rescue therapy for H pylori infection, with similar safety profiles and tolerability. PMID 25460556 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 750 mg —
Subject Amoxicillin Other / unclassified 1000 mg —
Comparator Clarithromycin Small molecule 500 mg —
Comparator Levofloxacin Small molecule 250 mg —
Subject Metronidazole Small molecule 500 mg —
Subject Rabeprazole Small molecule 20 mg —