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

NCT06811207 | Enrolling By Invitation Phase 3 DMC

• 2 other identifiers: IRB 202200416A3CMRPG8M1121
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori; Potassium-competitive acid blocker; Proton pump inhibitors; High-dose dual therapy; Antibiotic susceptibility

Outcome Measures

Primary Outcomes (1)

• 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%

  6 to 8 weeks after the completion of the 14-day treatment period.

Secondary Outcomes (1)

• Association Between Antibiotic Resistance and H. pylori Eradication Rate

  esistance testing at baseline, and eradication confirmation at 6 to 8 weeks post-treatment.

Other Outcomes (1)

• Antibiotic Resistance Profile of H. pylori Prior to Treatment

  Baseline (prior to treatment initiation).

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Vonoprazan; Drug: Amoxicillin

14-day PPI-Based High-Dose Dual Therapies

EXPERIMENTAL

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

Drug: Esomeprazole 40mg; Drug: Amoxicillin

Interventions

Vonoprazan DRUG

Vonoprazan (20 mg bid, for 14 days)

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

Esomeprazole 40mg DRUG

Esomeprazole (40 mg tid, for 14 days)

14-day PPI-Based High-Dose Dual Therapies

Amoxicillin DRUG

Amoxicillin (750 mg qid, for 14 days)

14-day PCAB-based high-dose dual therapy.; 14-day PPI-Based High-Dose Dual Therapies

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Previous H. pylori-eradication therapy,
• Ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks,
• Patients with an 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Others, 833, Taiwan

Location

Related Publications (3)

• Liu L, Shi H, Shi Y, Wang A, Guo N, Li F, Nahata MC. Vonoprazan-based therapies versus PPI-based therapies in patients with H. pylori infection: Systematic review and meta-analyses of randomized controlled trials. Helicobacter. 2024 May-Jun;29(3):e13094. doi: 10.1111/hel.13094.

  PMID: 38790090 BACKGROUND

• Gotoda T, Kusano C, Suzuki S, Horii T, Ichijima R, Ikehara H. Clinical impact of vonoprazan-based dual therapy with amoxicillin for H. pylori infection in a treatment-naive cohort of junior high school students in Japan. J Gastroenterol. 2020 Oct;55(10):969-976. doi: 10.1007/s00535-020-01709-4. Epub 2020 Jul 14.

  PMID: 32666199 BACKGROUND

• Tai WC, Lu LS, Yang SC, Wang HM, Wu CK, Yao CC, Huang PY, Lee YC, Chuah SK, Liang CM. Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line Helicobacter pylori eradication: a randomized controlled trial. Therap Adv Gastroenterol. 2025 Sep 20;18:17562848251378066. doi: 10.1177/17562848251378066. eCollection 2025.

  PMID: 40984972 DERIVED

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)