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NCT Number: NCT06250634

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

This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 14-90 years, no requirement for gender;
  • patients diagnosed as H. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13C/14C-UBT) or immuno-histochemical staining of biopsy specimens;
  • patients with no use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C/14C-UBT, and no H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H .pylori activity within the previous 2 weeks of 13C/14C-UBT;
  • patients without history of receiving H. pylori eradication therapy.

Exclusion criteria

  • patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
  • patients with allergy to penicillin or any research-program-related drugs;
  • patients with mental illness and communication disorders;
  • patients in pregnancy or lactation;
  • patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
  • patients who were participating in other clinical trials;
  • patients who were considered inappropriate for enrollment after evaluation by the researchers.

Treatment and study plan

esomeprazole + amoxicillin

Drug

esomeprazole enteric-coated tablets (AstraZeneca) 20mg four times daily and amoxicillin capsules (Hainan General Sanyang Pharmaceutical) 750mg four times daily

esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent

Drug

20mg twice daily of esomeprazole enteric-coated tablets, 1000 mg twice daily of amoxicillin capsules, 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical) and 165 mg three times daily of colloidal bismuth tartrate capsules (Shanxi Xinbaoyuan Pharmaceutical)

Vonoprazan + amoxicillin

Drug

20 mg twice daily of vonoprazan fumarate tablets (Takeda Pharmaceutical Company Limited) and 1000 mg three times daily of amoxicillin capsules (Hainan General Sanyang Pharmaceutical)

Vonoprazan + amoxicillin + clarithromycin

Drug

20 mg twice daily of vonoprazan fumarate tablets, 1000 mg twice daily of amoxicillin capsules and 500 mg twice daily of clarithromycin sustained-release tablets (Henan Fusen Pharmaceutical)

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: pre-intervention and at least 30 days post-intervention

    carbon-13/14 urea breath test

Secondary outcomes

  1. Adverse events

    Time frame: the 3rd, 7th, and 14th day during the intervention

  2. Compliance

    Time frame: the 14th day during the intervention

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • The Second People's Hospital of Huaihua
  • Yueyang Hospital of Traditional Chinese Medicine

Registry information

Official study title

Esomeprazole / Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection: a Multi-center, Prospective, Open-label, Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
May 29, 2024

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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