14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy

NCT05191888 | Unknown Phase 4 DMC

• 1 other identifier: KMUHIRB-F(I)-20210136
• Study Type: interventional
• Target: 906
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis.
2. 2.To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the "random number table generated by a computer similar to the lottery" to determine the treatment group) accept one of the following schemes (1:1:1).

Conditions

Helicobacter Pylori Eradication

Outcome Measures

Primary Outcomes (1)

• the rate of Helicobacter pylori

  Evaluate eradication outcome by 13C uear breath test

  6 week after finishing study drugs

Secondary Outcomes (1)

• Adverse drug reactions

  2weeks after finishing study drugs

Study Arms (3)

14-day vonoprazan high-dose two-in-one therapy

ACTIVE COMPARATOR

vonoprazan 20mg bid and amoxicillin 750mg qid

Drug: Vonoprazan and Amoxicillin

14-day vonoprazan triple therapy

ACTIVE COMPARATOR

vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid

Drug: Vonoprazan, Amoxicillin and Clarithromycin

14th Rabeprazole reverse mixed therapy

ACTIVE COMPARATOR

first 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid

Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole

Interventions

Vonoprazan and Amoxicillin DRUG

14-day vonoprazan high-dose two-in-one therapy

14-day vonoprazan high-dose two-in-one therapy

Vonoprazan, Amoxicillin and Clarithromycin DRUG

14-day vonoprazan triple therapy

14-day vonoprazan triple therapy

Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole DRUG

14th Rabeprazole reverse mixed therapy

14th Rabeprazole reverse mixed therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Related Publications (1)

• Hsu PI, Chen CL, Shih CA, Chen KY, Tai WC, Chuah SK, Lee CL, Tsay FW, Yang JC, Lei WY, Kuo CH, Shie CB, Lee HC, Yamaoka Y, Graham DY, Wu DC; Taiwan Acid-related Disease and Microbiota (TARD-M) Consortium. Vonoprazan High-Dose Dual, Vonoprazan Triple, and Rabeprazole Reverse Hybrid Therapies for First-Line Treatment of Helicobacter pylori Infection: A Multicenter Randomized Trial. Am J Gastroenterol. 2025 Jun 16. doi: 10.14309/ajg.0000000000003607. Online ahead of print.

  PMID: 40560185 DERIVED

MeSH Terms

Interventions

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

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; Erythromycin; Macrolides; Polyketides; Lactones; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Central Study Contacts

Deng-Chyang Wu, MD, PhD

CONTACT

886-7-*3121101; dechwu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 1. 14-day vonoprazan high-dose two-in-one therapy 2. 14-day vonoprazan triple therapy 3. 14th Rabeprazole reverse mixed therapy

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 14, 2022
• Study Start: August 6, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 14, 2022

Record last verified: 2022-01

Locations

TW (1)