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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00403364 |
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Date of registration:
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22/11/2006 |
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Primary sponsor: |
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Public title:
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Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial
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Scientific title:
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Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00403364 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Dino Vaira, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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S.Orsola/Malpighi Teaching Hospital, University of Bologna, Italy |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Helicobacter Pylori Infection
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Intervention(s)
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Drug: Placebo amoxicillin pantoprazole clarithromycin tinidazole
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Primary Outcome(s)
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13C urea breath test, upper endoscopy, histology, rapid urease test assessment
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Secondary Outcome(s)
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bacterial culture, and antibiotic resistance assessment
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Secondary ID(s)
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1112/2006
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No grant received
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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