Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy
Phase 4
- Conditions
- Eradication Rates of the Two Regimens
- Registration Number
- NCT01607918
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1300
Inclusion Criteria
- Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
- Written informed consents will be obtained from all patients prior to enrollment.
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Exclusion Criteria
Patients will be excluded from the study if any one of the following criteria is present:
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
- pregnant or lactating women,
- severe concurrent disease
- Patients who cannot give informed consent by himself or herself.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis 6 weeks C13-UBT will be used to assess the existence of H. pylori
- Secondary Outcome Measures
Name Time Method Incidence of adverse effects during eradication therapy to assess the adverse effects
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei,, Taiwan