Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-28 @ 7:13 AM
Study NCT ID:
NCT05577468
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2022-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 13\^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 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 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13\^C-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 13\^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 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 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13\^C-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:
False
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?: