We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Helicobacter Pylori Eradication With a New Sequential Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132171
First Posted: August 19, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
St. Orsola Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 18, 2005
First Posted: August 19, 2005
Last Update Posted: December 9, 2005
Last Verified: March 2002

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

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