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

Helicobacter Pylori Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06250634
• Other study ID #: Fast 21292, Fast 23359
• Status: Completed
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• esomeprazole + amoxicillin
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
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
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
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)

Locations

Country	Name	City	State
China	outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University	The Second People's Hospital of Huaihua, Yueyang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	carbon-13/14 urea breath test	pre-intervention and at least 30 days post-intervention
Secondary	Adverse events		the 3rd, 7th, and 14th day during the intervention
Secondary	Compliance		the 14th day during the intervention