Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.

NCT06412588 | Completed

• 1 other identifier: KY20240123-18
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection; Dual therapy

Outcome Measures

Primary Outcomes (1)

• HP eradication rate

  The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT

  4-6 weeks after the end of the last dose

Secondary Outcomes (1)

• Patient compliance

  Within 3 days after the end of treatment

Other Outcomes (1)

• Security observations

  Within 3 days after the end of treatment

Study Arms (3)

Group A Bismuth quadruple

ACTIVE COMPARATOR

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

Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

Group B Amoxicillin Dual therapy

EXPERIMENTAL

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

Drug: Vonoprazan+Amoxicillin

Group C doxycycline Dual therapy

EXPERIMENTAL

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

Drug: Vonoprazan+doxycycline

Interventions

Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days 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.

Also known as: Doxycycline-based Bismuth Quadruple Therapy

Group A Bismuth quadruple

Vonoprazan+Amoxicillin DRUG

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

Also known as: Vonoprazan+Amoxicillin Dual therapy

Group B Amoxicillin Dual therapy

Vonoprazan+doxycycline DRUG

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

Also known as: Vonoprazan+doxycycline Dual therapy

Group C doxycycline Dual therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old;
• Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
• 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;
• Voluntarily join this trial and sign the informed consent form.

You may not qualify if:

• Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
• Patients with confirmed active peptic ulcer;
• Patients who have received Helicobacter pylori eradication therapy within half a year;
• Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
• Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
• History of esophageal or gastric surgery;
• Pregnant or lactating women;
• Alcoholism
• Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
• Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
• Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

NanJing Frist Hospital

Nanjing, Jiangsu, 210006, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: June 15, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 10, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)