A Phase 3 interventional study of Vonoprazan and Esomeprazole 40mg in HELICOBACTER PYLORI INFECTIONS, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment
Background:
The key factors for success are the maintenance of intragastric pH > 6 and the drug resistance to antibiotics. Proton pump inhibitor (PPI)-based high-dose dual therapy is a novel anti-Helicobacter pylori (H. pylori) treatment. According to the investigators' previous study, the Esomeprazole-based high-dose dual therapy can achieve a higher eradication rate than standard triple therapy. The main reason for the high eradication rate was the use of high-dose esomeprazole which maintained 24-hour high intra-gastric pH. Another important reason was that investigators used only one antibiotic (Amoxicillin) with very low antibiotic resistance rates (0-2%). As compared to quadruple concomitant therapy which uses 3 antibiotics (clarithromycin, amoxicillin, and metronidazole), concomitant therapy could induce drug resistance which could affect public health issues.
Vonoprazan is a new gastric acid suppression agent, classified as a potassium-competitive acid blocker (PCAB). Its acid inhibition efficacy is superior to that of PPI. It has been evidenced that 7-day vonoprazan-based triple therapy achieved a higher eradication rate than 7-day PPI-based triple therapy in the first-line treatment of H. pylori infection but vonoprazan-based high-dose dual therapy can achieve a higher eradication rate than PPI-based thigh-dose dual therapy remains unclear.
Aims: (1) To test whether the efficacies of 14-day PCAB-based high-dose dual therapy can achieve a higher eradication rate than 14-day PPI-based high-dose dual therapy in the first-line treatment of H. pylori infection, (2) to examine the impacts of antibiotic resistance of H. pylori on the eradication efficacies of these two high-dose dual anti- H. pylori treatments.
Methods: The investigators will recruit 300 adult participants with H. pylori infection from Kaohsiung Chang Gung Memorial Hospital. Using a computer-generated randomized sequence, the investigators randomly allocated 150 patients to either 14-day high-dose dual therapy (vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days) or 150 patients (Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days). Participants are asked to return in the second week to assess drug compliance and adverse events. Post-treatment H. pylori status is assessed by a 13C-urea breath test at week 8. Additionally, antibiotic susceptibility of H. pylori will be examined. Finally, the rates of eradication, adverse events and compliance will be compared between two groups by chi-square test, and the host and bacterial factors influencing each efficacy of the regimen are assessed by multivariate analysis.
Expected results: The acid inhibition efficacy of PCAB is superior to that of PPI. The investigators expect the PCAB-based high-dose dual therapy can achieve a better H. pylori eradication rate the PPA-based high-dose dual therapy. Minor adverse effects can be expected in each group of participants.
Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 238 are open to participants now.
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1. At least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis are prospectively recruited for this pilot study
Exclusion Criteria:
vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days
Drug: Vonoprazan · Drug: Amoxicillin
Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days
Drug: Esomeprazole 40mg · Drug: Amoxicillin
Vonoprazan (20 mg bid, for 14 days)
Esomeprazole (40 mg tid, for 14 days)
Amoxicillin (750 mg qid, for 14 days)
Proportion of Participants With Eradication of H. pylori Confirmed by Urea Breath Test (UBT)
1. Description: This outcome will measure the percentage of participants in each treatment group (PCAB-based dual therapy and PPI-based dual therapy) who achieve H. pylori eradication. 2. Definition of Eradication: Eradication is defined as a negative result on the Urea Breath Test (UBT). 3. Calculation Method: The proportion of eradicated participants will be calculated as: (Number of participants with confirmed eradication by UBT) / (Total participants analyzed)×100%
Time frame: 6 to 8 weeks after the completion of the 14-day treatment period.
Association Between Antibiotic Resistance and H. pylori Eradication Rate
1. Description: This outcome will evaluate whether pre-treatment antibiotic resistance (e.g., amoxicillin resistance) is associated with the eradication success rate of PCAB-based and PPI-based high-dose dual therapies. 2. Statistical Analysis: The correlation between antibiotic resistance status (resistant vs. susceptible) and eradication outcome (eradicated vs. not eradicated) will be analyzed using appropriate logistic regression models or chi-square tests.
Time frame: esistance testing at baseline, and eradication confirmation at 6 to 8 weeks post-treatment.
Antibiotic Resistance Profile of H. pylori Prior to Treatment
1. Description: This outcome will assess the pre-treatment antibiotic resistance of H. pylori strains collected from participants. 2. Resistance Measurement: Resistance to amoxicillin and other relevant antibiotics will be determined through bacterial culture and susceptibility testing (e.g., MIC values in μg/mL or resistant/susceptible categories).
Time frame: Baseline (prior to treatment initiation).
Plan to share: No — There are no plans to share individual participant data (IPD) from this study. The data include sensitive information that may compromise participant privacy, even if de-identified. Ethical considerations and privacy regulations prevent data sharing.
This study is status unknown, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esomeprazole
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