Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
Phase 4
Completed
- Conditions
- Helicobacter Infection
- Interventions
- Registration Number
- NCT00841854
- Lead Sponsor
- Asan Medical Center
- Brief Summary
At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
Inclusion Criteria
- H. pylori infection
- Aged between 18-80 years
- Are willing to received eradication therapy for H. pylori
Exclusion Criteria
- Children and teenagers aged less than 18 years or over 80 years
- Previous eradication therapy for H. pylori
- History of gastrectomy
- Previous allergic reaction to antibiotics
- Use of prompt pump inhibitors and antibiotics 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PBMT14 bismuth pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days PBMT7 bismuth pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days PBMT7 pantoprazole pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days PBMT7 tetracycline pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days PBMT7 metronidazole pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days PBMT14 pantoprazole pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days PBMT14 metronidazole pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days PBMT14 tetracycline pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
- Primary Outcome Measures
Name Time Method Whether the two week group yield a higher eradication rate comparing to the one week group. At least four week after completion of treatment
- Secondary Outcome Measures
Name Time Method side effect four weeks after completion of medication
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of