Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole
NCT ID: NCT06318104
Last Updated: 2024-03-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
160 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-19
Study Completion Date
2025-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Helicobacter Pylori Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Tegoprazan Group
Tegoprazan 50 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days
Group Type
ACTIVE_COMPARATOR
Tegoprazan
Intervention Type
DRUG
Tegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Esomeprazole Group
Esomeprazole 40 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days
Group Type
ACTIVE_COMPARATOR
Esomeprazole 40mg
Intervention Type
DRUG
Esomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Interventions
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Tegoprazan
Tegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Intervention Type
DRUG
Esomeprazole 40mg
Esomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Intervention Type
DRUG
Other Intervention Names
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P-CAB
PPI
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Hospital General de México Dr. Eduardo Liceaga
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Yoali Maribel Velasco Santiago
Doctor assigned to gastroenterology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Yoali M Velasco Santiago
Role: PRINCIPAL_INVESTIGATOR
Hospital General de México Dr. Eduardo Liceaga
Central Contacts
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References
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Related Links
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https://gco.iarc.fr/
Review: Global Cancer Observatory
Other Identifiers
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DI/24/310/03/4
Identifier Type: -
Identifier Source: org_study_id
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