Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Eradication rate
Study Overview
Brief Summary
The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18-70 years old
- •Patients with H.pylori infection (13C/14C-urea breath test)
- •Patients without previous treatment for H. pylori eradication
Exclusion Criteria
- •Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%
- •Patients with active gastrointestinal bleeding
- •Patients with a history of upper gastrointestinal surgery
- •Patients allergic to treatment drugs
- •Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
- •Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
- •Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
- •Patients who are unwilling or incapable to provide informed consents
Arms & Interventions
14-day dual regimen
Intervention: vonoprazan+amoxicillin (Drug)
10-day dual regimen
Intervention: vonoprazan+amoxicillin (Drug)
7-day quadruple regimen
Intervention: vonoprazan+amoxicillin+tetracycline+bismuth (Drug)
Outcomes
Primary Outcomes
Eradication rate
Time Frame: Six weeks after treatment
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Secondary Outcomes
- Rate of adverse reactions(Immediately after treatment)
- Patient compliance(Immediately after treatment)
Investigators
Yanqing Li
Ph.D
Shandong University