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

NCT ID: NCT06250634

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 806 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2024-05-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Double group ( Esomeprazole )

Group Type: EXPERIMENTAL

esomeprazole + amoxicillin

Intervention Type: DRUG

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

Quadruple group ( Esomeprazole )

Group Type: ACTIVE_COMPARATOR

esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent

Intervention Type: 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)

Double group ( Vonoprazan )

Group Type: EXPERIMENTAL

Vonoprazan + amoxicillin

Intervention Type: 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)

Triple group (Vonoprazan )

Group Type: ACTIVE_COMPARATOR

Vonoprazan + amoxicillin + clarithromycin

Intervention Type: 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)

Interventions

esomeprazole + amoxicillin

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

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. patients aged 14-90 years, no requirement for gender;

2. 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;

3. 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;

4. patients without history of receiving H. pylori eradication therapy.

Exclusion Criteria

1. 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;

2. patients with allergy to penicillin or any research-program-related drugs;

3. patients with mental illness and communication disorders;

4. patients in pregnancy or lactation;

5. patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;

6. patients who were participating in other clinical trials;

7. patients who were considered inappropriate for enrollment after evaluation by the researchers.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second People's Hospital of Huaihua

UNKNOWN

Sponsor Role: collaborator

Yueyang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Fen Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Changsha, Hunan, China

Countries

China

Other Identifiers

Fast 21292, Fast 23359

Identifier Type: -

Identifier Source: org_study_id