Helicobacter Pylori Eradication With a New Sequential Treatment

Last updated: March 17, 2021
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Completed

Phase

3

Condition

Gastrointestinal Diseases And Disorders

Heartburn (Pediatric)

Heartburn

Treatment

N/A

Clinical Study ID

NCT00132171
66/2000/J
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of active H. pylori infection
  • Age >18 years

Exclusion

Exclusion Criteria:

  • Allergy to drug administered
  • Liver or kidney failure
  • Pregnancy
  • Previous treatment for H. pylori infection

Study Design

Total Participants: 1000
Study Start date:
January 01, 2001
Estimated Completion Date:
December 31, 2001

Study 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.

Connect with a study center

  • Gastroenterology - Nuovo Regina Margherita Hospital

    Rome, 00153
    Italy

    Site Not Available

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