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Clinical trial

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

ID
Name
VGHKS18-CT4-24
Description
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.
Trial arms
Trial start
2018-09-03
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
10d bismuth quadruple therapy
Other names:
rabeprazole 20 mg bid, tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, metronidazole 250 mg qid
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
Arms:
14d hybrid therapy
Other names:
rabeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, metronidazole 500 mg bid
14D high-dose dual therapy
rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
Arms:
14d high-dose dual therapy
Other names:
rabeprazole 20 mg qid, amoxicillin 750 mg qid
Size
918
Primary endpoint
Number of Participants in Which H. Pylori Was Eradicated
sixth week after the end of anti- H. pylori therapy
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 918, 'type': 'ACTUAL'}}
Updated at
2023-10-26

1 organization

3 products

1 indication

Organization
Kaohsiung Veterans General Hospital
Product
10d Bismuth Quadruple Therapy
Indication
Helicobacter pylori infection
Product
14d hybrid therapy
Product
14D high-dose dual therapy