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

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