Helicobacter Pylori Eradication With a New Sequential Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00132171
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : October 20, 2005
Information provided by:
St. Orsola Hospital

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment
Study Start Date : January 2001
Study Completion Date : December 2001

Primary Outcome Measures :
  1. Helicobacter pylori eradication rate

Secondary Outcome Measures :
  1. Compliance to therapy

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00132171

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

Publications of Results: Identifier: NCT00132171     History of Changes
Other Study ID Numbers: 66/2000/J
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: October 20, 2005
Last Verified: March 2002

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

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