Vonoprazan Hp Dual or Triple Eradication Regimes

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

Official Title
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Efficacy and Safety of Helicobacter Pylori Eradication Dual or Triple Regimes Using Vonoprazan as the Antacid

Conditions
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Helicobacter Pylori

Intervention / Treatment
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* Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)
* Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14)
* Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7)
* Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)
* Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)<br>Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days | Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)<br>* VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days<br>|
| Experimental: Vonoprazan Fumarate+Amoxycillin 14days (VA14)<br>Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days | Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14)<br>* VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days<br>|
| Experimental: Vonoprazan Fumarate+Amoxycillin 7days (VA7)<br>Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days | Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7)<br>* VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days<br>|
| Experimental: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)<br>Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days | Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)<br>* VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days<br>|
| Experimental: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)<br>Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days | Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)<br>* VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter Pylori eradication rate | The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication | 28 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms effective rates | symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe | 14 days of treatment, and 28 days after treatment | 
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain. | 14 days of treatment, and 28 days after treatment |