Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05901051
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2023-02-24
Brief Title:
High-dose Dual Therapy With Different Administration Frequencies
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Randomized and Controlled Clinical Study of High-dose Dual Therapy With Different Administration Frequencies in the Treatment of Helicobacter Pylori
Status:
COMPLETED
Status Verified Date:
2023-02
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:
This study is a single center randomized controlled clinical study The enrolled patients are HP positive They are diagnosed as HP positive by rapid urease test andor 13C urea breath test According to the declaration of Helsinki 327 patients will be included in this study After obtaining the written informed consent of the patients HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate adverse reactions compliance antibiotic resistance of HP and its impact on HP eradication
Detailed Description:
According to relevant literature research amoxicillin TID groups including before meal group and after meal group were given Vonorasen Takeda China 20mg bid and Amoxicillin 10 TID Zhejiang Jinhua Kangenbei biopharmaceutical Co Ltd Amoxicillin Qid group was given Vonorasen Takeda China 20mg bid and Amoxicillin 075 Qid Zhejiang Jinhua Kangenbei biopharmaceutical Co Ltd all the drugs were purchased by the patients from the hospital The three groups were treated for 14 days respectively and 13C urea breath test was performed 6 weeks after drug withdrawal The negative ones were judged as HP eradication
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