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

Kaohsiung Veterans General Hospital

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: 10-day sequential therapy; Drug: 7-day standard triple therapy; Drug: 7-day quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01769365

VGHKS99-CT7-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 307 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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307 participants in 3 patient groups

7-day quadruple therapy

Experimental group

Description:

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

Treatment:

Drug: 7-day quadruple therapy

10-day sequential therapy

Experimental group

Description:

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.

Treatment:

Drug: 10-day sequential therapy

7-day standard triple therapy

Active Comparator group

Description:

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.

Treatment:

Drug: 7-day standard triple therapy