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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318104
• Other study ID #: DI/24/310/03/4
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 19, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Hospital General de México Dr. Eduardo Liceaga
• Contact: Yoali M Velasco Santiago
• Phone: 525523213021
• Email: yoavesan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 28, 2025
• Est. primary completion date: November 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Tegoprazan
Tegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
• Esomeprazole 40mg
Esomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de México Dr. Eduardo Liceaga

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Brief Medication Questionnaire	Identify the factors associated with medication consumption, by applying the Brief Medication Questionnaire on day 7 and 14 of treatment, via telephone call and in person.	Two weeks
Secondary	Percentage of patients with adherence to treatment	Adherence to treatment will be evaluated by calculating the percentage of compliance and tablet count, which is based on the count of the number of tablets left in the container compared to the amount initially indicated, and the time between the indication and the count. The percentage of adherence to eradication treatment will be compared in patients treated with the scheme based on tegoprazan vs. proton pump inhibitor.	Two weeks
Secondary	Report all 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.	Two months

External Links

•   Review: Global Cancer Observatory