Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-02-01

Brief Summary

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

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Detailed Description

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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

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H. Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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high dose amoxicillin with keverprazan group

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

Group Type ACTIVE_COMPARATOR

Keverprazan

Intervention Type DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

low dose amoxicillin with keverprazan group

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

Group Type EXPERIMENTAL

Keverprazan

Intervention Type DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Interventions

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Keverprazan

Potassium-competitive acid blocker

Intervention Type DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Other Intervention Names

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Potassium-competitive acid blocker Antibiotic for H. pylori eradication

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No