Title
Helicobacter Pylori Eradication With a New Sequential Treatment
High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment
Phase
Phase 3Lead Sponsor
University of BolognaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Helicobacter Pylori Infection Non Ulcer Dyspepsia Duodenal Ulcer Gastric Ulcer Chronic Active Gastritis ...Intervention/Treatment
metronidazole procaine benzylpenicillin clarithromycin omeprazole ...Study Participants
1000Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. The study aimed to assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection.
One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (20 mg twice daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5 days] or standard 7-day therapy [corrected] [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g), all twice daily]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.
Inclusion Criteria: Presence of active H. pylori infection Age >18 years Exclusion Criteria: Allergy to drug administered Liver or kidney failure Pregnancy Previous treatment for H. pylori infection