Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy

NCT06156085

Helicobacter Pylori Infection

COMPLETED PHASE4

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

NCT06349486

Helicobacter Pylori Eradication

RECRUITING NA

Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection

NCT06250634

Helicobacter Pylori Infection

COMPLETED NA

Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection

NCT04713670

H. Pylori Infection

RECRUITING PHASE4

Helicobacter Pylori and Vonoprazan Dual Therapy

NCT05649709

Helicobacter Pylori

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HELICOBACTER PYLORI INFECTIONS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators will recruit 300 adult participants with H. pylori infection from Kaohsiung Chang Gung Memorial Hospital. Using a computer-generated randomized sequence, we 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 participants (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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

14-day PCAB-based high-dose dual therapy.

vonoprazan 20 mg bid, and amoxicillin 750mg qid. for 14 days

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

Vonoprazan (20 mg bid, for 14 days)

Amoxicillin

Intervention Type DRUG

Amoxicillin (750 mg qid, for 14 days)

14-day PPI-Based High-Dose Dual Therapies

Esomeprezole 40 mg tid, and amoxicillin 750mg qid. for 14 days

Group Type EXPERIMENTAL

Esomeprazole 40mg

Intervention Type DRUG

Esomeprazole (40 mg tid, for 14 days)

Amoxicillin

Intervention Type DRUG

Amoxicillin (750 mg qid, for 14 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vonoprazan

Vonoprazan (20 mg bid, for 14 days)

Intervention Type DRUG

Esomeprazole 40mg

Esomeprazole (40 mg tid, for 14 days)

Intervention Type DRUG

Amoxicillin

Amoxicillin (750 mg qid, for 14 days)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. At least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis are prospectively recruited for this pilot study

Exclusion Criteria

1. Previous H. pylori-eradication therapy,
2. Ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks,
3. Patients with an allergic history to the medications used,
4. Patients with previous gastric surgery,
5. The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
6. Pregnant women.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No