Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412640
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Eradication of Helicobacter Pylori by 14-day Dual Therapy of Keverprazan in Combination With Low-dose and High-dose Amoxicillin a Prospective Single-center Developmental-label Randomized Controlled Study
Status:
NOT_YET_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:
The purpose of this study was to evaluate the efficacy and safety of keverprazan with different doses of amoxicillin for Helicobacter Pylori
Detailed Description:
This study is a prospective single-center open-label randomized parallel-controlled trial A total of 268 H pylori positive patients needed to be recruited and were randomized into 2 groups in 11 ratio Group A was the control group and subjects were required to take keverprazan 20mgbid and amoxicillin 10gtid for 14 days Group B was the experimental group and subjects were required to take keverprazan 20mgbid and amoxicillin 10gtid for 14 days All the above regimens were used for eradication of H pylori During the 14-day eradication treatment all subjects were instructed and asked to record their adverse drug reactions and compliance On days 7 and 14 of treatment researchers followed up with patients via WeChat or phone to determine adverse reactions and compliance and observed and recorded whether subjects experienced any adverse reactions such as nausea diarrhea dizziness bitter taste in the mouth rash and constipation Subjects were seen again 4 weeks after the end of treatment to check for H pylori eradication by 13C-UBT or 14C-UBT Patients were encouraged but not required to undergo tongue and fecal flora testing before and after H pylori eradication to determine the short-term effects of different doses of amoxicillin in combination with keverprazan for 14 days on the patients tongue and intestinal flora
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