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OpenTrials
Completed

NCT Number: NCT06950489

Tegoprazan and Amoxicillin Dual Therapy

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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. H. pylori eradication rates

    Time frame: 6 weeks

    Urea breath test after completing H. pylori eradication regimen

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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