NCT06412640

Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

Eradication of Helicobacter Pylori by 14-day Dual Therapy of Keverprazan in Combination With Low-dose and High-dose Amoxicillin: a Prospective, Single-center, Developmental-label, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of keverprazan with different doses of amoxicillin for Helicobacter Pylori.

Detailed description

This study is a prospective, single-center, open-label, randomized, parallel-controlled trial. A total of 268 H. pylori positive patients needed to be recruited and were randomized into 2 groups in 1:1 ratio, Group A was the control group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. Group B was the experimental group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. All the above regimens were used for eradication of H. pylori. During the 14-day eradication treatment, all subjects were instructed and asked to record their adverse drug reactions and compliance. On days 7 and 14 of treatment, researchers followed up with patients via WeChat or phone to determine adverse reactions and compliance, and observed and recorded whether subjects experienced any adverse reactions such as nausea, diarrhea, dizziness, bitter taste in the mouth, rash, and constipation. Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT. Patients were encouraged, but not required, to undergo tongue and fecal flora testing before and after H. pylori eradication to determine the short-term effects of different doses of amoxicillin in combination with keverprazan for 14 days on the patient's tongue and intestinal flora.

Conditions

• H. Pylori Infection

Interventions

Type	Name	Description
DRUG	Keverprazan	Potassium-competitive acid blocker
DRUG	Amoxicillin	Antibiotic for H. pylori eradication

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2024-05-14
• Last updated: 2024-05-14