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

NCT06250634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2024-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

esomeprazole + amoxicillin

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

DRUG

esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent

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)

DRUG

Vonoprazan + amoxicillin

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)

DRUG

Vonoprazan + amoxicillin + clarithromycin

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)

Sponsors & Collaborators

  • The Second People's Hospital of Huaihua

    collaborator UNKNOWN

  • Yueyang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-10
Primary Completion
2024-05-10
Completion
2024-05-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250634 on ClinicalTrials.gov