Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

918 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2021-12-31

Brief Summary

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Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection.

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Detailed Description

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Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H. pylori infection in several important international consensuses. However, it is associated with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple therapy developed by our study group can achieve a higher eradication rate than levofloxacin triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains unanswered.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10d bismuth quadruple therapy

rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days.

Group Type ACTIVE_COMPARATOR

10d bismuth quadruple therapy

Intervention Type DRUG

rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days

14d hybrid therapy

a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days.

Group Type EXPERIMENTAL

14d hybrid therapy

Intervention Type DRUG

a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days

14d high-dose dual therapy

rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days

Group Type EXPERIMENTAL

14D high-dose dual therapy

Intervention Type DRUG

rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days

Interventions

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10d bismuth quadruple therapy

rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days

Intervention Type DRUG

14d hybrid therapy

a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days

Intervention Type DRUG

14D high-dose dual therapy

rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days

Intervention Type DRUG

Other Intervention Names

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rabeprazole 20 mg bid tripotassium dicitrate bismuthate 300mg qid tetracycline 500 mg qid metronidazole 250 mg qid rabeprazole 20 mg bid amoxicillin 1 g bid clarithromycin 500 mg bid metronidazole 500 mg bid rabeprazole 20 mg qid amoxicillin 750 mg qid

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 or bismuth 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No