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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: 7-day quadruple therapy
* Drug: 10-day sequential therapy
* Drug: 7-day standard triple therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7-day quadruple therapy<br>pantoprazole 40 mg twice daily for 7 days, clarithromycin 500 mg twice daily for 7 days, amoxicillin 1 g twice daily for 7 days, metronidazole 500 mg twice daily for 7 days | Drug: 7-day quadruple therapy<br>* pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days<br>* Other names: Pantoprazole, amoxicillin, clarithromycin, metronidazole;|
| Experimental: 10-day sequential therapy<br>pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days. | Drug: 10-day sequential therapy<br>* pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days<br>* Other names: sequential group;|
| Active Comparator: 7-day standard triple therapy<br>pantoprazole 40 mg twice daily for 7 days, clarithromycin 500 mg twice daily for 7 days, amoxicillin 1 g twice daily for 7 days. | Drug: 7-day standard triple therapy<br>* pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days<br>* Other names: pantoprazole, clarithromycin, amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori infection