Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Whether the two week group yield a higher eradication rate comparing to the one week group.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PBMT7
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
Intervention: pantoprazole (Drug)
PBMT7
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
Intervention: bismuth (Drug)
PBMT7
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
Intervention: metronidazole (Drug)
PBMT7
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
Intervention: tetracycline (Drug)
PBMT14
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Intervention: pantoprazole (Drug)
PBMT14
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Intervention: bismuth (Drug)
PBMT14
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Intervention: metronidazole (Drug)
PBMT14
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Intervention: tetracycline (Drug)
Outcomes
Primary Outcomes
Whether the two week group yield a higher eradication rate comparing to the one week group.
Time Frame: At least four week after completion of treatment
Secondary Outcomes
- side effect(four weeks after completion of medication)
Investigators
Hwoon-Yong Jung
M.D.
Asan Medical Center