Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05419674
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 393
- having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
- underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
- with no historical treatment for helicobacter pylori infection.
- administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
- with previous esophageal or gastric surgery
- with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
- allergy to any of the study drugs
- participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description groupA: dual therapy (vonoprazan+amoxicillin) Amoxicillin vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days group B: dual therapy (rabeprazole+amoxicillin) Amoxicillin rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days groupA: dual therapy (vonoprazan+amoxicillin) Vonoprazan vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days group C: bismuth-containing quadruple therapy Rabeprazole rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days group C: bismuth-containing quadruple therapy Amoxicillin rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days group C: bismuth-containing quadruple therapy Colloidal bismuth pectin rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days group C: bismuth-containing quadruple therapy Clarithromycin rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days group B: dual therapy (rabeprazole+amoxicillin) Rabeprazole rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days
- Primary Outcome Measures
Name Time Method Helicobacter pylori Eradication Rate Six to eight weeks after completion of the medication Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
- Secondary Outcome Measures
Name Time Method Rate of Adverse Drug Reaction(ADR) Within 7 days after completion of therapy Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).
Compliance Rate Within 7 days after completion of therapy Compliance was defined as poor when they had taken less than 80% of the total medication.
Trial Locations
- Locations (1)
Second Affiliated Hospital of Zhejiang University, School of Medicine
🇨🇳Hangzhou, Zhejiang, China