- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132171
Helicobacter Pylori Eradication With a New Sequential Treatment
March 17, 2021 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
High Eradication Rates of Helicobacter Pylori 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00153
- Gastroenterology - Nuovo Regina Margherita Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Helicobacter pylori eradication rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Compliance to therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Angelo Zullo, MD, Nuovo Regina Margherita Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Primary Completion
December 6, 2022
Study Completion
December 1, 2001
Study Registration Dates
First Submitted
August 18, 2005
First Submitted That Met QC Criteria
August 18, 2005
First Posted (Estimate)
August 19, 2005
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 66/2000/J
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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