Vonoprazan Hp Dual or Triple Eradication Regimes
Efficacy and Safety of Helicobacter Pylori Eradication Dual or Triple Regimes Using Vonoprazan as the Antacid
1 other identifier
interventional
500
1 country
1
Brief Summary
To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedOctober 20, 2022
October 1, 2022
10 months
April 6, 2022
October 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
symptoms effective rates
14 days of treatment, and 28 days after treatment
adverse events
14 days of treatment, and 28 days after treatment
Study Arms (5)
Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)
ACTIVE COMPARATORVonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days
Vonoprazan Fumarate+Amoxycillin 14days (VA14)
EXPERIMENTALVonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days
Vonoprazan Fumarate+Amoxycillin 7days (VA7)
EXPERIMENTALVonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days
Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)
EXPERIMENTALVonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days
Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)
EXPERIMENTALVonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days
Interventions
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
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
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
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
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032, China
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Han
Xijing Hosipital of Digestive Disease
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 6, 2022
First Posted
April 25, 2022
Study Start
April 25, 2022
Primary Completion
February 28, 2023
Study Completion
March 31, 2023
Last Updated
October 20, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share