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

Sponsor

Kaohsiung Veterans General Hospital. (Other)

Overall Status

Recruiting

CT.gov ID

NCT03779074

Collaborator

(none)

918

Enrollment

Location

Arms

51.9

Anticipated Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: 10d bismuth quadruple therapy Drug: 14d hybrid therapy Drug: 14D high-dose dual therapy	Phase 3

Detailed Description

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

918 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacies of Hybrid, High-dose Dual and Bismuth Quadruple Therapies for the First-line Anti-H Pylori Treatment and Tetracycline-levofloxacin Quadruple Therapy for the Second-line Anti-H Pylori Treatment - a Multicentre Randomized Trial

Actual Study Start Date :

Sep 3, 2018

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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 Other Names: rabeprazole 20 mg bid tripotassium dicitrate bismuthate 300mg qid tetracycline 500 mg qid metronidazole 250 mg qid
Experimental: 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.	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 Other Names: rabeprazole 20 mg bid amoxicillin 1 g bid clarithromycin 500 mg bid metronidazole 500 mg bid
Experimental: 14d high-dose dual therapy rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days	Drug: 14D high-dose dual therapy rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days Other Names: rabeprazole 20 mg qid amoxicillin 750 mg qid

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: 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

Other Names:

rabeprazole 20 mg bid

tripotassium dicitrate bismuthate 300mg qid

tetracycline 500 mg qid

metronidazole 250 mg qid

Experimental: 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.

Drug: 14d hybrid therapy

Other Names:

rabeprazole 20 mg bid

amoxicillin 1 g bid

clarithromycin 500 mg bid

metronidazole 500 mg bid

Experimental: 14d high-dose dual therapy

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

Drug: 14D high-dose dual therapy

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

Other Names:

rabeprazole 20 mg qid

amoxicillin 750 mg qid

Outcome Measures

Primary Outcome Measures

Number of Participants in Which H. Pylori Was Eradicated [sixth week after the end of anti- H. pylori therapy]
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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 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