Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection
Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial
1 other identifier
interventional
393
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 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
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 16, 2023
June 1, 2022
1 year
June 10, 2022
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Helicobacter pylori Eradication Rate
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.
Six to eight weeks after completion of the medication
Secondary Outcomes (2)
Rate of Adverse Drug Reaction(ADR)
Within 7 days after completion of therapy
Compliance Rate
Within 7 days after completion of therapy
Study Arms (3)
groupA: dual therapy (vonoprazan+amoxicillin)
EXPERIMENTALvonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
group B: dual therapy (rabeprazole+amoxicillin)
EXPERIMENTALrabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days
group C: bismuth-containing quadruple therapy
ACTIVE COMPARATORrabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days
Interventions
Proton pump inhibitor
Antibiotic for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
- SPONSOR
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 15, 2022
Study Start
August 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
February 16, 2023
Record last verified: 2022-06