Status:
COMPLETED
Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Helicobacter Infections
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line ...
Detailed Description
Determination of H. pylori status Prior to enrollment, the status of H. pylori infection will be determined by (1) rapid urease test (CLO test, Kimberly-Clark, USA) from antrum biopsy, (2) histologica...
Eligibility Criteria
Inclusion
- Asymptomatic subjects or symptomatic patients with H. pylori infection who are aged greater than 20 years and are willing to received eradication therapy for H. pylori
Exclusion
- Children and teenagers aged less than 20 years
- Previous eradication therapy for H. pylori
- History of gastrectomy
- Gastric malignancy, including adenocarcinoma and lymphoma
- Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (lansoprazole)
- Use of prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the recent 4 weeks
- Active upper GI bleeding in the recent 1 week
- Contraindication to treatment drugs
- Pregnant or lactating women
- Severe concurrent disease or malignancy.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT00816140
Start Date
June 1 2007
End Date
July 1 2009
Last Update
April 22 2011
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10002