Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431737
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H Pylori Eradication
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy A Propensity Score Matching Analysis
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Gastric acid depressant play a major role in an H pylori eradication therapy by 1 increasing the intragastric pH which improves antibiotic stability and bioavailability 2 increasing the intragastric pH to 6 or more which prompts H pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria such as amoxicillin 3 increasing the concentration of antibiotics in the stomach Of antimicrobial agents against H pylori amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall Therefore amoxicillins bactericidal effect requires the bacteria to be replicating Amoxicillin is excreted by the kidneys the plasma half-life is approximately 1 hour and the bactericidal effect is time dependent Theoretically amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration MIC However in most H pylori eradication therapies amoxicillin is given twice daily where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin Because most strains of H pylori are sensitive to amoxicillin 3 or 4 times daily administration may be appropriate to increase the H pylori eradication success Nevertheless data regarding the amoxicillin dosing interval for successful H pylori eradication are lacking
Detailed Description:
The investigators aim to compare the H pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy Secondary outcomes are treatment compliance and drug-related adverse event rates
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