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

Hospital General de México Dr. Eduardo Liceaga

Status and phase: Not yet enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Esomeprazole 40mg; Drug: Tegoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT06318104

DI/24/310/03/4

Details and patient eligibility

About

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.

Full description

160 patients with a diagnosis of H.P. infection with indication for treatment in accordance with the IV Mexican Consensus on Helicobacter Pylori, evaluated in the Gastroenterology outpatient clinic, will be recruited. Participants will be randomized into two groups, one group will receive tegoprazan 50 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days and the second group will receive esomeprazole 40 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days. Through complementary studies, telephone calls and application of questionnaires, adherence to treatment will be evaluated and adverse events will be monitored, and once the treatment period is completed, a breath test will be performed between days 28-42 to verify eradication, thereby evaluating effectiveness.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Tegoprazan Group

Active Comparator group

Description:

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

Treatment:

Drug: Tegoprazan

Esomeprazole Group

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole 40mg