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Completed

NCT Number: NCT00132171

Helicobacter Pylori Eradication With a New Sequential Treatment

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.

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Key information

Conditions

Helicobacter Pylori Infection Chronic Active Gastritis Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastric Ulcer Gastritis Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Non Ulcer Dyspepsia Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastroenterology - Nuovo Regina Margherita Hospital

Rome, 00153, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sequential therapy

Drug

Primary outcomes

  1. Helicobacter pylori eradication rate

Secondary outcomes

  1. Compliance to therapy

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment

Important dates

Study start
2001
Study completion
2001
First posted
Aug 19, 2005
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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