Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Second Affiliated Hospital, School of Medicine, Zhejiang University
414 participants
Feb 19, 2024
INTERVENTIONAL
Conditions
Summary
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
Eligibility
Inclusion Criteria5
- Adult patients aged 18 to 65 years old, regardless of gender;
- H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
- No previous history of H. pylori eradication therapy;
- Subjects able to independently complete the recording of the subject diary card;
- Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.
Exclusion Criteria9
- Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
- Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
- Previous history of esophageal or gastric surgery;
- Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
- Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
- Female participants who are pregnant, breastfeeding;
- Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
- Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
- Deemed unsuitable for participation in the study by the investigator for any other reason.
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Interventions
Keverprazan dual therapy for 10 days (K10 group): Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
Rabeprazole quadruple therapy for 14 days (R14 group): Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07122024