Helicobacter Pylori Eradication With a New Sequential Treatment
Primary Purpose
Helicobacter Pylori Infection, Non Ulcer Dyspepsia, Duodenal Ulcer
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Sequential therapy
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Eradication, Sequential therapy, Standard therapy
Eligibility 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
Sites / Locations
- Gastroenterology - Nuovo Regina Margherita Hospital
Outcomes
Primary Outcome Measures
Helicobacter pylori eradication rate
Secondary Outcome Measures
Compliance to therapy
Full Information
NCT ID
NCT00132171
First Posted
August 18, 2005
Last Updated
March 17, 2021
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT00132171
Brief Title
Helicobacter Pylori Eradication With a New Sequential Treatment
Official Title
High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Non Ulcer Dyspepsia, Duodenal Ulcer, Gastric Ulcer, Chronic Active Gastritis, Gastritis
Keywords
Helicobacter pylori, Eradication, Sequential therapy, Standard therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sequential therapy
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Secondary Outcome Measure Information:
Title
Compliance to therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Zullo, MD
Organizational Affiliation
Nuovo Regina Margherita Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology - Nuovo Regina Margherita Hospital
City
Rome
ZIP/Postal Code
00153
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
12641522
Citation
Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadia C, Fornari F, Pilati S, Mete LS, Merla A, Poti R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003 Mar 1;17(5):719-26. doi: 10.1046/j.1365-2036.2003.01461.x. Erratum In: Aliment Pharmacol Ther. 2003 May 1;17(9):1205.
Results Reference
result
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Helicobacter Pylori Eradication With a New Sequential Treatment
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