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Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole

NCT06318104 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-03-19

No results posted yet for this study

Summary

In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Tegoprazan

Tegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.

DRUG

Esomeprazole 40mg

Esomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.

Sponsors & Collaborators

  • Hospital General de México Dr. Eduardo Liceaga

    lead OTHER_GOV

Principal Investigators

  • Yoali M Velasco Santiago · Hospital General de México Dr. Eduardo Liceaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2024-11-29
Completion
2025-02-28

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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 NCT06318104 on ClinicalTrials.gov