Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.

NCT ID: NCT06412588

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 810 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-12-31

Brief Summary

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Detailed Description

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Conditions

Helicobacter Pylori Infection

Study Design

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

Study Groups

Group A Bismuth quadruple

Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days

Group Type: ACTIVE_COMPARATOR

Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

Intervention Type: DRUG

Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.

Group B Amoxicillin Dual therapy

Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days

Group Type: EXPERIMENTAL

Vonoprazan+Amoxicillin

Intervention Type: DRUG

Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.

Group C doxycycline Dual therapy

Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days

Group Type: EXPERIMENTAL

Vonoprazan+doxycycline

Intervention Type: DRUG

Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.

Interventions

Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.

Intervention Type: DRUG

Vonoprazan+Amoxicillin

Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.

Intervention Type: DRUG

Vonoprazan+doxycycline

Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.

Intervention Type: DRUG

Other Intervention Names

Doxycycline-based Bismuth Quadruple Therapy; Vonoprazan+Amoxicillin Dual therapy; Vonoprazan+doxycycline Dual therapy

Eligibility Criteria

Inclusion Criteria

1. Age 18-65 years old;

2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;

3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;

4. Voluntarily join this trial and sign the informed consent form.

Exclusion Criteria

1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);

2. Patients with confirmed active peptic ulcer;

3. Patients who have received Helicobacter pylori eradication therapy within half a year;

4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;

5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;

6. History of esophageal or gastric surgery;

7. Pregnant or lactating women;

8. Alcoholism

9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;

10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;

11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Zhang

Director of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhenyu Zhang

Role: CONTACT

zhangzhenyu808@126.com

18951670222

Other Identifiers

KY20240123-18

Identifier Type: -

Identifier Source: org_study_id