Vonoprazan Hp Dual or Triple Eradication Regimes

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

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

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiaqiang Dong; Phone Number: 86-029-84771506; Email: dongjiaqiang1988@163.com
• Study Contact Backup: Name: Yongquan Shi; Phone Number: 86-029-84771515; Email: shiyquan@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hosipital of Digestive Disease
      • Contact: Ying Han, Ph.D; Phone Number: 86-29-84771539; Email: hanying@fmmu.edu.cn
      • Contact: Yongquan Shi, Ph.D; Phone Number: 86-29-84771515; Email: shiyquan@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Principal Investigator: Ying Han, Xijing Hosipital of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Amoxicillin; Clarithromycin; Tetracycline; Furazolidone
• Other Study ID Numbers: XJLL-KY20222010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No