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

March 12, 2024 updated by: Yoali Maribel Velasco Santiago, Hospital General de México Dr. Eduardo Liceaga

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tegoprazan Group
Tegoprazan 50 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days
Drug: Tegoprazan
Tegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Other Names:
  • P-CAB
Active Comparator: Esomeprazole Group
Esomeprazole 40 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days
Drug: Esomeprazole 40mg
Esomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Other Names:
  • PPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment by determining the eradication rate
Time Frame: Two months
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
Time Frame: Two months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Medication Questionnaire
Time Frame: Two weeks
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
Percentage of patients with adherence to treatment
Time Frame: Two weeks
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
Report all Treatment-related adverse events
Time Frame: Two months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de México Dr. Eduardo Liceaga

Investigators

  • Principal Investigator: Yoali M Velasco Santiago, Hospital General de México Dr. Eduardo Liceaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 19, 2024

Primary Completion (Estimated)

November 29, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DI/24/310/03/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For legal confidentiality reasons.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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