Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870683
Status:
RECRUITING
Last Update Posted:
2023-07-11
First Post:
2023-05-07
Brief Title:
Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection SHARE2301
Sponsor:
Yanqing Li
Organization:
Shandong University
Study Overview
Official Title:
Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication a Prospective Multicenter Randomized Controlled Study SHARE2301
Status:
RECRUITING
Status Verified Date:
2023-07
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:
Helicobacter pylori H pylori infection is a common global infectious disease of the gastrointestinal tract Helicobacter pylori eradication can effectively prevent the development of stomach cancer Progressive application of dual therapy for the eradication of Helicobacter pylori Tegoprazan a Potassium-Competitive Acid Blockers The efficacy of P-CAB agents represented by vonoprazan in H pylori eradication therapy has been widely verified
Detailed Description:
In 1989 it was suggested that amoxicillin combined with PPI could eradicate Hp infection and in 2015 a prospective multicenter randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 966 with dual therapy for primary treatment of Hp infection and the results of intention-to-treat analysis were as high as 953 953 In 2020 a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment In terms of dosing days multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H pylori
Tegoprazan a Potassium-Competitive Acid Blockers P-CAB is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression The efficacy of P-CAB agents represented by vonoprazan in H pylori eradication therapy has been widely verified 2022 tegoprazan was approved by the State Drug Administration for the new indication of eradication of H pylori infection in adults in combination with appropriate antimicrobial therapy and its efficacy in clinical application has not yet been verified
Tegoprazan a Potassium-Competitive Acid Blockers P-CAB is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression The efficacy of P-CAB agents represented by vonoprazan in H pylori eradication therapy has been widely verified 2022 tegoprazan was approved by the State Drug Administration for the new indication of eradication of H pylori infection in adults in combination with appropriate antimicrobial therapy and its efficacy in clinical application has not yet been verified
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