Helicobacter Pylori Eradication With a New Sequential Treatment

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Completed; Phase 3

Conditions: Gastritis; Helicobacter Pylori Infection; Non Ulcer Dyspepsia; Gastric Ulcer; Chronic Active Gastritis; Duodenal Ulcer

Treatments: Drug: Sequential therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00132171

66/2000/J

Details and patient eligibility

About

Eradication 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.

Full description

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)