Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514274
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on The Efficacy and Safety of BerberineAmoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride vonorasan and amoxicillin for the primary eradication of Helicobacter pyloriIt is hypothesized that berberine hydrochloride amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapyPatients diagnosed with H pylori infection will be randomly divided into one of the above treatments At week 6 follow-up visits a urea breath testrapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication
Detailed Description:
The study will include three phases screening treatment and follow-up Screening this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent One of urea breath testrapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations
Treatment Subjects are randomly assigned to treatment and will be treated for 14 days A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17
Follow-up includes one visits Approximately 28 days after the end of treatment Eradication of H Pylori will be confirmed by one of urea breath testrapid urease test or helicobacter pylori stool antigen test
Treatment Subjects are randomly assigned to treatment and will be treated for 14 days A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17
Follow-up includes one visits Approximately 28 days after the end of treatment Eradication of H Pylori will be confirmed by one of urea breath testrapid urease test or helicobacter pylori stool antigen test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None