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Helicobacter Pylori Eradication With a New Sequential Treatment

This study has been completed.
Sponsor:
Information provided by:
St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT00132171
First received: August 18, 2005
Last updated: October 19, 2005
Last verified: March 2002
History of Changes
  Purpose

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.


Condition Intervention Phase
Helicobacter Pylori Infection
Non Ulcer Dyspepsia
Duodenal Ulcer
Gastric Ulcer
Chronic Active Gastritis
Gastritis
 Drug: Sequential therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • Helicobacter pylori eradication rate

Secondary Outcome Measures:
  • Compliance to therapy

Estimated Enrollment: 1000
Study Start Date: January 2001
Estimated Study Completion Date: December 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132171

Locations
Italy
Gastroenterology - Nuovo Regina Margherita Hospital
Rome, Italy, 00153
Sponsors and Collaborators
St. Orsola Hospital
Investigators
Principal Investigator: Angelo Zullo, MD Nuovo Regina Margherita Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00132171     History of Changes
Other Study ID Numbers: 66/2000/J
Study First Received: August 18, 2005
Last Updated: October 19, 2005
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by St. Orsola Hospital:
Helicobacter pylori
Eradication
Sequential therapy
Standard therapy

Additional relevant MeSH terms:
Duodenal Ulcer
Dyspepsia
Gastritis
Stomach Ulcer
Ulcer
Helicobacter Infections
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Stomach Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013