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

NCT06318104 | Not Yet Recruiting Phase 4

• 1 other identifier: DI/24/310/03/4
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Tegoprazan; Esomeprazole; Effectiveness; Safety

Outcome Measures

Primary Outcomes (2)

• Response to treatment by determining the eradication rate

  The eradication rate will be measured by a carbon-13 urea breath test that will verify the eradication of Helicobacter pylori. The eradication rate of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.

  Two months

• Compared Treatment-related adverse events

  Treatment-related adverse events will be evaluated by complementary serum studies and interrogated according to system organ classes and preferred terms using MedDRA. Adverse events related to the treatment of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.

  Two months

Secondary Outcomes (3)

• Brief Medication Questionnaire

  Two weeks

• Percentage of patients with adherence to treatment

  Two weeks

• Report all Treatment-related adverse events

  Two months

Study Arms (2)

Tegoprazan Group

ACTIVE COMPARATOR

Tegoprazan 50 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days

Drug: Tegoprazan

Esomeprazole Group

ACTIVE COMPARATOR

Esomeprazole 40 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days

Drug: Esomeprazole 40mg

Interventions

Tegoprazan DRUG

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

Also known as: P-CAB

Tegoprazan Group

Esomeprazole 40mg DRUG

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

Also known as: PPI

Esomeprazole Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-degree relatives with a history of gastric cancer.
• Clinical diagnosis of uninvestigated dyspepsia in patients under 50 years of age.
• Diagnosis of Gastric Mucosa - Aassociated Lymphoid Tissue (MALT) Lymphoma.
• Iron deficiency anemia.
• Unexplained thrombocytopenic purpura.

You may not qualify if:

• Patients who have social coverage.
• Previous eradication treatment for Helicobacter Pylori.
• Acute upper gastrointestinal bleeding and active gastric and/or duodenal ulcer.
• History of surgery that affects gastric acid secretion (vagotomy, gastrointestinal resection).
• Disorders of gastric acid hypersecretion (Zollinger-Ellison Syndrome).
• Any serious hematological, cardiovascular, neurological, nephro-urological, hepatic and pulmonary disorders.
• Pregnancy or lactation.
• Allergy to any of the study medications.

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

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Related Links

• Review: Global Cancer Observatory

MeSH Terms

Interventions

tegoprazan; Esomeprazole

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

Study Officials

• Yoali M Velasco Santiago

  Hospital General de México Dr. Eduardo Liceaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoali M Velasco Santiago

CONTACT

525523213021; yoavesan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor assigned to gastroenterology

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 19, 2024
• Study Start: April 19, 2024
• Primary Completion: November 29, 2024
• Study Completion: February 28, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share