Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: H. Pylori Infection

Treatments: Drug: Keverprazan; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT06412640

KY20240419-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with Helicobacter pylori positivity through 13C-UBT or 14C-UBT
2. Patients who have not received eradication treatment for Helicobacter pylori in the past, or who have failed eradication in the early stage but have not received eradication treatment within six months
3. Voluntarily participate in this experiment and sign an informed consent form

Exclusion criteria

1. Allergies to research drugs (such as those allergic to penicillin, amoxicillin, keverprazan)
2. Patients with peptic ulcer
3. Patients who have received Helicobacter pylori eradication treatment within six months
4. Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study
5. Using corticosteroids, non steroidal anti-inflammatory drugs, or anticoagulants
6. Those who are using atazanavir, nelfinavir, rilpivirine, itraconazole, tyrosine kinase inhibitors (imatinib, gefitinib, etc.), digoxin, and methyl digoxin
7. History of esophageal or gastric surgery
8. Pregnant or lactating women
9. Suffering from serious concomitant diseases such as liver disease, cardiovascular disease, lung disease, or kidney disease
10. Excessive drinking
11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant neoplastic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

high dose amoxicillin with keverprazan group

Active Comparator group

Description:

Patients need to take keverprazan 20mg bid and amoxicillin 1000mg tid for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Keverprazan

low dose amoxicillin with keverprazan group

Experimental group

Description:

Patients need to take keverprazan 20mg bid and amoxicillin 1000mg bid for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Keverprazan