Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection

Phase 4

Completed

Interventions: Drug: 7-day quadruple therapy
Drug: 10-day sequential therapy
Drug: 7-day standard triple therapy

Brief Summary: To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

Detailed Description: The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.

A total of 306 subjects are enrolled into this study.

H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.

Recruitment & Eligibility

Inclusion Criteria

Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria

previous H. pylori-eradication therapy
ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks
patients with allergic history to the medications used
patients with previous gastric surgery
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
pregnant women

Arm && Interventions

Group	Intervention	Description
7-day quadruple therapy	7-day quadruple therapy	1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days, 4. metronidazole 500 mg twice daily for 7 days
10-day sequential therapy	10-day sequential therapy	1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by 2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days.
7-day standard triple therapy	7-day standard triple therapy	1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Eradication of Helicobacter Pylori	at the 6th week after the end of anti- H. pylori therapy	Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Secondary Outcome Measures