Helicobacter Pylori Eradication With a New Sequential Treatment

Phase 3

Completed

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

• Registration Number: NCT00132171
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2001-12
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate

Secondary Outcome Measures

Name	Time	Method
Compliance to therapy

Trial Locations

Locations (1)

Gastroenterology - Nuovo Regina Margherita Hospital; 🇮🇹 Rome, Italy