Clinical trial NCT06318104: Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole
Official title: Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Tegoprazan
Esomeprazole
Effectiveness
Safety
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
First posted: 2024-03-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response to treatment by determining the eradication rate
timeFrame: Two months
measure: Compared Treatment-related adverse events
timeFrame: Two months
Secondary outcomes:
measure: Brief Medication Questionnaire
timeFrame: Two weeks
measure: Percentage of patients with adherence to treatment
timeFrame: Two weeks
measure: Report all Treatment-related adverse events
timeFrame: Two months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General de México Dr. Eduardo Liceaga
name: Yoali M Velasco Santiago
role: PRINCIPAL_INVESTIGATOR
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