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Keverprazan Combined With Amoxicillin for the Treatment of Helicobacter Pylori

NCT06851468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-04-29

No results posted yet for this study

Summary

The objective of this clinical trial is to determine whether the interventional behavioral drug Keverprazan in combined with amoxicillin, is effective in treating initial Helicobacter pylori infections in adults and to assess the safety of Keverprazan in the treatment of Helicobacter pylori.

The primary questions it aims to address are:

1. What is the eradication rate of Keverprazan in individuals with the first-time H. pylori infection?
2. What adverse effects do participants experience while taking the drug Keverprazan?
3. To clarify the microecological changes of Keverprazan on the intestinal tract. The researchers will compare the experimental group receiving Keverprazan in combination with amoxicillin dual therapy to the control group receiving Esomeprazole in combination with amoxicillin dual therapy to assess the efficacy and safety of Keverprazan in treating the primary population infected with Helicobacter pylori.

Participants will:

1. Take Keverprazan, esomeprazole, and amoxicillin daily for 14 days;
2. Researchers will record participants' medication adherence on days 7 and 14, as well as any adverse drug reactions;
3. Participants will undergo a urea breath test one month after discontinuing the medication, and the researchers will record the eradication rate.
4. 20 Participants in the experimental group and the control group were randomly selected to collect stool for examination 1 month before and 1 month after treatment.

Conditions

  • Helicobacter Pylori

Interventions

DRUG

Keverprazan

Keverprazan ：Dosage form: tablet；dose：20mg；dosage: 2 times a day；duration: 14 days

DRUG

Esomeprazole

Esomeprazole：Dosage form: capsule；dose：40mg；dosage: 2 times a day；duration: 14 days

DRUG

Amoxicillin

Amoxicillin：Dosage form: capsule；dose：1g；dosage: 3 times a day；duration: 14 days。

Sponsors & Collaborators

  • Key Laboratory for Gastrointestinal Diseases of Gansu Province

    lead OTHER

Principal Investigators

  • Qian Ren, doctorate · associate professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06851468 on ClinicalTrials.gov