Tegoprazan and Amoxicillin Dual Therapy

A Feasibility Study of Tegoprazan and Amoxicillin Dual Therapy for the Treatment of Helicobacter Pylori

Dual therapy for Helicobacter pylori refers to a treatment regimen that combines two agents: a potent acid suppressor (such as a proton pump inhibitor [PPI] or a potassium-competitive acid blocker [PCAB]) and the antibiotic amoxicillin. This approach is increasingly recognized as a viable alternative to traditional triple or quadruple therapies, particularly in the context of rising resistance to other antibiotics such as clarithromycin and metronidazole. Potent acid suppression increases the stability and activity of amoxicillin against H. pylori by maintaining a higher gastric pH, which is essential for optimal amoxicillin effect. High-dose dual therapy (e.g., amoxicillin 1,000 mg three times daily + standard dose of PPI three or four times daily for 14 days) has demonstrated eradication rates of 90%. In 2015, vonoprazan, a novel P-CAB, was launched in Japan and used as an alternative for PPIs for eradicating H. pylori. Dual therapy with vonoprazan and amoxicillin is particularly effective, with cure rates comparable to triple therapy and superior outcomes in clarithromycin-resistant infections. Dual therapy is generally well tolerated, with adverse event rates similar to or lower than those seen with triple or quadruple regimens. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for H. pylori eradication. However, there was no study of tegoprazan and amoxicillin dual therapy for the treatment of H. pylori.

Study Overview

• Status: Completed
• Conditions: H.Pylori Infection

Detailed Description

The investigators aim to evaluate the H. pylori eradication success rate and treatment compliance of tegoprazan and amoxicillin dual therapy.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 04401
    • Digestive Disease Center, Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

H. pylori-infected patients

Description

Inclusion Criteria:

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

Exclusion Criteria:

• Age < 20 or > 80 years
• Anemia (serum hemoglobin level < 10 g/dL)
• Severe systemic disease
• Advanced chronic liver disease
• Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
• History of H. pylori eradication
• Drug allergy to antibiotics
• History of gastric surgery
• Recent history of upper gastrointestinal bleeding

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. pylori eradication rates	Urea breath test after completing H. pylori eradication regimen	6 weeks

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SCH-HP-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No