Status:
COMPLETED
Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-controlled Trial
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
To assess if a sequential treatment regimen better eradicates H. pylori than does a triple drug regimen in adults with dyspepsia or peptic ulcer disease.
Detailed Description
Background: Antimicrobial resistance has decreased eradication rates for H. pylori worldwide. Objective: To assess if a sequential treatment regimen better eradicates H. pylori than does a triple dru...
Eligibility Criteria
Inclusion
- Helicobacter pylori infected patients \> 18 years
Exclusion
- previous H. pylori eradication treatment;
- Use of proton pump inhibitors, H2-receptor antagonists, bismuth preparations and antibiotics in the previous 4 weeks;
- Concomitant anticoagulant or ketoconazole use, due to the potential of interaction with the study medications;
- Zollinger-Ellison syndrome;
- Previous surgery of the esophagus and/or upper gastrointestinal tract (with the exception of appendectomy, polypectomy and cholecystectomy);
- Severe or unstable cardiovascular, pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematological disorder; any other clinically significant medical condition that could increase the risk to the study participants; malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer or Barrett esophagus with high grade dysplasia;
- Drug or medication abuse within the past year;
- Severe psychiatric or neurological disorders;
- Pregnant or nursing women sexually active women of child bearing potential who were not willing to practice medically acceptable contraception (oral contraceptives; inject able/implantable or mechanical devices as well as vasectomy of the sexual partner) for the entire duration of the study.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00403364
Start Date
July 1 2003
End Date
February 1 2006
Last Update
March 18 2021
Active Locations (1)
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1
S.Orsola/Malpighi Teaching Hospital, University
Bologna, Italy, 40138