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Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori

NCT05577468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 561

Last updated 2024-01-10

No results posted yet for this study

Summary

This study is a multicenter, randomized, double-blind, double-dummy, phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China.

Screening phase: After signing the informed consent form, subjects will be determined for Helicobacter pylori infection by 13\^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 ratio to receive the tegoprazan-containing bismuth quadruple therapy (hereinafter referred to as the tegoprazan group) or esomeprazole-containing bismuth quadruple therapy (hereinafter referred to as the esomeprazole group).

Treatment phase: Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days.

Follow-up phase: Within 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13\^C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Tegoprazan

tegoprazan-containing bismuth quadruple therapy or Esomeprazole-containing bismuth quadruple therapy; Route of administration: oral;

Sponsors & Collaborators

  • Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2023-09-30
Completion
2023-09-30

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 NCT05577468 on ClinicalTrials.gov