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CompletedNCT00132171Updated Mar 18, 2021

Helicobacter Pylori Eradication With a New Sequential Treatment

A Phase 3 interventional study of Sequential therapy in Helicobacter Pylori Infection, Non Ulcer Dyspepsia and Duodenal Ulcer, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

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

Keywords

  • Helicobacter pylori
  • Eradication
  • Sequential therapy
  • Standard therapy
03

In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's enrollment of 1,000 is above the median of 200 across 113 interventional studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to drug administered
  • Liver or kidney failure
  • Pregnancy
  • Previous treatment for H. pylori infection
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants

Interventions

  • DrugSequential therapy
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What researchers measure

Primary outcomes

  1. Helicobacter pylori eradication rate

Secondary outcomes

  1. Compliance to therapy

07

Study locations

1 site
  • Gastroenterology - Nuovo Regina Margherita Hospital
    Rome, 00153, Italy
08

References and documents

Publications

  • 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. Erratum In: Aliment Pharmacol Ther. 2003 May 1;17(9):1205. PubMed 12641522 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00132171
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
First posted
Aug 19, 2005
Start date
Jan 2001
Completion
Dec 2001
Last update
Mar 18, 2021

Study contacts

Angelo Zullo, MD
principal investigator · Nuovo Regina Margherita Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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