Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-28
Brief Title:
Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole
Sponsor:
Hospital General de México Dr Eduardo Liceaga
Organization:
Hospital General de México Dr Eduardo Liceaga
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Mexico quadruple therapy is used to treat Helicobacter pylori HP 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 HP 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 HP 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 HP 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None