Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Helicobacter Infection

Treatments: Drug: pantoprazole; Drug: tetracycline; Drug: bismuth; Drug: metronidazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00841854

2008-0088

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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199 participants in 2 patient groups

PBMT7

Active Comparator group

Description:

pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days

Treatment:

Drug: pantoprazole

Drug: metronidazole

Drug: bismuth

Drug: tetracycline

PBMT14

Active Comparator group

Description:

pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days

Treatment:

Drug: pantoprazole

Drug: metronidazole

Drug: bismuth

Drug: tetracycline