Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05577468
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2022-10-09
Brief Title:
Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori
Sponsor:
Shandong Luoxin Pharmaceutical Group Stock Co Ltd
Organization:
Shandong Luoxin Pharmaceutical Group Stock Co Ltd
Study Overview
Official Title:
A Multi-center Randomized Double-blind Double-dummy Phase III Clinical Study to Evaluate the Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori
Status:
COMPLETED
Status Verified Date:
2024-01
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 multicenter randomized double-blind double-dummy phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China
Screening phase After signing the informed consent form subjects will be determined for Helicobacter pylori infection by 13C-urea breath test UBThistological testing and bacterial culture during the screening period Subjects who meet all screening criteria will be randomized in a 11 ratio to receive the tegoprazan-containing bismuth quadruple therapy hereinafter referred to as the tegoprazan group or esomeprazole-containing bismuth quadruple therapy hereinafter referred to as the esomeprazole group
Treatment phase Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days
Follow-up phase Within 297 days after the last study drug treatment subjects will return to the study site for efficacy and safety assessments 13C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment
Screening phase After signing the informed consent form subjects will be determined for Helicobacter pylori infection by 13C-urea breath test UBThistological testing and bacterial culture during the screening period Subjects who meet all screening criteria will be randomized in a 11 ratio to receive the tegoprazan-containing bismuth quadruple therapy hereinafter referred to as the tegoprazan group or esomeprazole-containing bismuth quadruple therapy hereinafter referred to as the esomeprazole group
Treatment phase Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days
Follow-up phase Within 297 days after the last study drug treatment subjects will return to the study site for efficacy and safety assessments 13C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment
Detailed Description:
None
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