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NCT Number: NCT06431737

Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication

Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Soonchunhyang University Hospital

Seoul, South Korea

About this study

The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates.

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

Amoxicillin

Drug

Tegoprazan 50 mg bid, amoxicillin 1000 mg bid or 500 mg qid, clarithromycin 500 mg bid for 14 days

Primary outcomes

  1. H. pylori eradication rates

    Time frame: 6 weeks

    Urea breath test after completing H. pylori eradication regimen

Secondary outcomes

  1. Treatment compliance

    Time frame: 6 weeks

    Assessment of patients' numbers completing H. pylori eradication regimen

  2. Drug-related adverse event rate

    Time frame: 6 weeks

    Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy: A Propensity Score Matching Analysis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 29, 2024
Registry last updated
Apr 30, 2025

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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