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NCT00132171 Clinical Trial

Helicobacter Pylori Eradication With a New Sequential Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:
High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00132171
Other study ID # 66/2000/J
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2001
Est. completion date December 2001

Study information
Verified date March 2021
Source IRCCS Azienda Ospedaliero-Universitaria di Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sequential therapy

Locations
Country Name City State
Italy Gastroenterology - Nuovo Regina Margherita Hospital Rome

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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, Papadìa C, Fornari F, Pilati S, Mete LS, Merla A, Potì R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Helicobacter pylori eradication rate
Secondary Compliance to therapy
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