Vonoprazan Hp Dual or Triple Eradication Regimes

Xijing Hospital of Digestive Diseases

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori

Treatments: Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14); Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7); Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7); Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14); Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)

Study type: Interventional

Funder types: Other

Identifiers

NCT05345210

XJLL-KY20222010

Details and patient eligibility

About

To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 70 years old, both gender is eligiable;
• Patients with definite Helicobacter Pylori infection (13C/14C urea breath test, rapid urease test and fecal Helicobacter Pylori antigen test positive) ;
• Voluntary to accept Helicobacter Pylori eradication treatment;
• Females of childbearing age are required to use medically acceptable contraceptive methods during the trial and within 30 days after the trial.

Exclusion criteria

• Patients with contraindications to the study drug or allergic to the study drug;
• Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
• Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (at least 2 weeks before the examination for Helicobacter Pylori infection);
• Pregnant and lactating women;
• Have received upper gastrointestinal surgery;
• Symptoms of dysphagia;
• Evidence of bleeding or iron deficiency anemia;
• have a history of malignant tumor;
• History of drug or alcohol abuse within the past 1 year;
• Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, and platelet aggregation inhibitors (except aspirin ≤100 mg/d);
• Persons with mental disorders;
• Received other clinical trials within the past 3 months;
• Refused to sign the informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 5 patient groups

Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)

Active Comparator group

Description:

Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days

Treatment:

Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)

Vonoprazan Fumarate+Amoxycillin 14days (VA14)

Experimental group

Description:

Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days

Treatment:

Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14)

Vonoprazan Fumarate+Amoxycillin 7days (VA7)

Experimental group

Description:

Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days

Treatment:

Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7)

Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)

Experimental group

Description:

Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days

Treatment:

Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)

Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)

Experimental group

Description:

Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days

Treatment:

Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)