Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

May 9, 2024 updated by: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: high dose amoxicillin with keverprazan group
Patients need to take keverprazan 20mg bid and amoxicillin 1000mg tid for 14 days.
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Other Names:
  • Antibiotic for H. pylori eradication
Drug: Keverprazan
Potassium-competitive acid blocker
Other Names:
  • Potassium-competitive acid blocker
Experimental: low dose amoxicillin with keverprazan group
Patients need to take keverprazan 20mg bid and amoxicillin 1000mg bid for 14 days.
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Other Names:
  • Antibiotic for H. pylori eradication
Drug: Keverprazan
Potassium-competitive acid blocker
Other Names:
  • Potassium-competitive acid blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication rate
Time Frame: at least four weeks after completion of the medication
Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT.
at least four weeks after completion of the medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance Rate
Time Frame: Within 7 days after completion of therapy
Compliance was defined as poor when they had taken less than 80% of the total medication
Within 7 days after completion of therapy
Adverse even
Time Frame: Within 7 days after completion of therapy
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
Within 7 days after completion of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20240419-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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