Helicobacter Pylori Eradication With a New Sequential Treatment

NCT ID: NCT00132171

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2001-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Sequential therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Principal Investigators

Angelo Zullo, MD

Role: PRINCIPAL_INVESTIGATOR

Nuovo Regina Margherita Hospital

Locations

Gastroenterology - Nuovo Regina Margherita Hospital

Rome, , Italy

Countries

Italy

References

Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadia C, Fornari F, Pilati S, Mete LS, Merla A, Poti R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003 Mar 1;17(5):719-26. doi: 10.1046/j.1365-2036.2003.01461.x.

Reference Type: RESULT

PMID: 12641522 (View on PubMed)

Other Identifiers

66/2000/J

Identifier Type: -

Identifier Source: org_study_id