Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication

NCT06349486 | Recruiting

• 1 other identifier: KMUHIRB-F(II)-20230179
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
2. 2.To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

Conditions

Helicobacter Pylori Eradication

Outcome Measures

Primary Outcomes (1)

• the eradication rate of Helicobacter pylori

  evalute eradication outcome by 13C urea breath test

  8 week after finishing study drugs

Secondary Outcomes (1)

• genotype analysis

  1 day

Study Arms (3)

bismuth-amoxicillin-vonoprazan triple therapy

ACTIVE COMPARATOR

vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day

Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate

vonoprazan-amoxicillin dual therapy

ACTIVE COMPARATOR

vonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day

Drug: vonoprazan, amoxicillin

proton pump inhibitor-based standard triple therapy

ACTIVE COMPARATOR

rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day

Drug: rabeprazole, amoxicillin, clarithromycin

Interventions

vonoprazan, amoxicillin, tripotassium dicitrate bismuthate DRUG

bismuth-amoxicillin-vonoprazan triple therapy

bismuth-amoxicillin-vonoprazan triple therapy

vonoprazan, amoxicillin DRUG

vonoprazan-amoxicillin dual therapy

vonoprazan-amoxicillin dual therapy

rabeprazole, amoxicillin, clarithromycin DRUG

proton pump inhibitor-based standard triple therapy

proton pump inhibitor-based standard triple therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.

You may not qualify if:

• Those who have ever received Helicobacter pylori sterilization treatment.
• Those who are allergic to the drugs used in this research.
• Those who have had stomach surgery.
• Those with severe liver cirrhosis or uremia or malignant tumors.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Rabeprazole; Clarithromycin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Erythromycin; Macrolides; Polyketides; Lactones

Central Study Contacts

Deng-Chyang Wu, MD, PHD

CONTACT

88673121101; dechwu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: 1. bismuth-amoxicillin-vonoprazan triple therapy 2. vonoprazan-amoxicillin dual therapy 3. proton pump inhibitor-based standard triple therapy

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: November 28, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-04

Locations

TW (1)