Overview

Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-controlled Trial

Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
St. Orsola Hospital
Treatments:
Amoxicillin
Clarithromycin
Pantoprazole
Tinidazole
Criteria
Inclusion Criteria:

- Helicobacter pylori infected patients > 18 years

Exclusion Criteria:

- 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.