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
• Status: Completed
• Phase: Phase 3
• 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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Active Gastritis
• Duodenal Ulcer
• Dyspepsia
• Gastric Ulcer
• Gastritis
• Helicobacter Pylori Infection
• Non Ulcer Dyspepsia
• Stomach Ulcer
• Ulcer

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