Status:
UNKNOWN
Vonoprazan Hp Dual or Triple Eradication Regimes
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Helicobacter Pylori
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05345210
Start Date
April 25 2022
End Date
March 31 2023
Last Update
October 20 2022
Active Locations (1)
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1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032