Keverprazan Combined With Amoxicillin for the Treatment of Helicobacter Pylori

NCT06851468 | Completed

• 1 other identifier: MZLKPZ001
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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. 1.What is the eradication rate of Keverprazan in individuals with the first-time H. pylori infection?
2. 2.What adverse effects do participants experience while taking the drug Keverprazan?
3. 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.
4. 4.Take Keverprazan, esomeprazole, and amoxicillin daily for 14 days;
5. 5.Researchers will record participants' medication adherence on days 7 and 14, as well as any adverse drug reactions;
6. 6.Participants will undergo a urea breath test one month after discontinuing the medication, and the researchers will record the eradication rate.
7. 7.20 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

Outcome Measures

Primary Outcomes (1)

• Post-treatment eradication rate of primary treatment participants

  If the 13C/14C-UBT test of the initial treatment participants was negative at 1 month after 14 days of treatment, the eradication was successful

  up to 2 months

Study Arms (2)

Keverprazan combined with amoxicillin

EXPERIMENTAL

Drug：Keverprazan、Dosage form: tablet, dose: 20mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days；

Drug: Keverprazan; Drug: Amoxicillin

Esomeprazole combined with amoxicillin

ACTIVE COMPARATOR

Drug：Esomeprazole、Dosage form: capsule, dose: 40mg, frequency: twice a day, duration: 14 days； Drug：amoxicillin、Dosage form: capsule, dose: 1g, frequency: dreimal taeglich, duration: 14 days；

Drug: Esomeprazole; Drug: Amoxicillin

Interventions

Keverprazan DRUG

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

Keverprazan combined with amoxicillin

Esomeprazole DRUG

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

Esomeprazole combined with amoxicillin

Amoxicillin DRUG

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

Esomeprazole combined with amoxicillin; Keverprazan combined with amoxicillin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )18\~65 years old, gender is not limited;
• \) H. pylori infection was diagnosed by urea breath test;
• \) Did not receive H. pylori eradication therapy;
• \) Informed and consented to participate in this study.

You may not qualify if:

• \) Have serious systemic diseases, major organs such as heart, lung, brain diseases, liver and kidney insufficiency, malignant tumors or other diseases;
• \) Active peptic ulcer with bleeding, perforation, obstruction, cancer and other complications; And subjects with a past or current history of Zolling-Ellison syndrome's disorders;
• \) Allergic history of penicillin and regimen related drugs;
• \) Excessive acid-suppressing drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, etc. were used within 2 weeks before enrollment, or antibiotics were used 4 weeks before enrollment;
• \) Pregnant or lactating women;
• \) Other participants were deemed unsuitable by the researchers.

Sponsors & Collaborators

• Key Laboratory for Gastrointestinal Diseases of Gansu Province: lead

Study Sites (1)

KeyLabGIDiseasesGansu

Lanzhou, Gansu, 730000, China

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Qian Ren, doctorate

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: March 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)