Skip to content

Helicobacter Pylori Eradication With a New Sequential Treatment

High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00132171
Enrollment
1000
Registered
2005-08-19
Start date
2001-01-31
Completion date
2001-12-31
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Helicobacter pylori, Eradication, Sequential therapy, Standard therapy

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.

Interventions

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate

Secondary

MeasureTime frame
Compliance to therapy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026