Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02835560
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2016-07-09
Brief Title:
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
Sponsor:
Livzon Pharmaceutical Group Inc
Organization:
Livzon Pharmaceutical Group Inc
Study Overview
Official Title:
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
Status:
COMPLETED
Status Verified Date:
2012-06
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 compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg Bismuth Potassium Citrate 220mg Clarithromycin 500mg and Amoxicillin Cap Amoxicillin 1000mg BID on the first line eradication treatment of Hpylori
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcerincluding scar stage gastritis and dyspepsia confirmed to be Hpylori positive patients in the biopsy and UBT test For 14 days participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg Bismuth Potassium Citrate 220mg Clarithromycin 500mg and Amoxicillin Cap Amoxicillin 1000mg BID After treatment the healing rate was evaluated in the UBT test and Biopsy at 495days from the first day dosing
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcerincluding scar stage gastritis and dyspepsia confirmed to be Hpylori positive patients in the biopsy and UBT test For 14 days participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg Bismuth Potassium Citrate 220mg Clarithromycin 500mg and Amoxicillin Cap Amoxicillin 1000mg BID After treatment the healing rate was evaluated in the UBT test and Biopsy at 495days from the first day dosing
Detailed Description:
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg Bismuth Potassium Citrate 220mgClarithromycin 500mg and Amoxicillin CapAmoxicillin 1000mg BID on the first line eradication treatment of Hpylori
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcerincluding scar stage gastritis and dyspepsia confirmed to be Hpylori positive patients in the biopsy and UBT test For 14 days Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg Bismuth Potassium Citrate 220mgClarithromycin 500mg and Amoxicillin Cap Amoxicillin 1000mg BID After treatment The healing rate was evaluated in the UBT test and Biopsy at 495days from the first day dosing
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcerincluding scar stage gastritis and dyspepsia confirmed to be Hpylori positive patients in the biopsy and UBT test For 14 days Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg Bismuth Potassium Citrate 220mgClarithromycin 500mg and Amoxicillin Cap Amoxicillin 1000mg BID After treatment The healing rate was evaluated in the UBT test and Biopsy at 495days from the first day dosing
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