Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04198363
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2019-12-12
Brief Title:
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan TAK-438 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral TAK-438 20 mg Compared to Esomeprazole 20 mg Twice Daily in Subjects With Helicobacter Pylori Infection
Status:
COMPLETED
Status Verified Date:
2022-10
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 is to evaluate the efficacy of helicobacter pylori HP eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants
Detailed Description:
The drug being tested in this study is called vonoprazan TAK-438 Vonoprazan is being tested to treat people who have helicobacter pylori infection
The study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Vonoprazan 20 mg
Esomeprazole 20 mg
All participants will be asked to take one tablet in combination with bismuth containing quadruple therapy amoxicillin clarithromycin and bismuth potassium citrate twice at the same time each day throughout the study
This multi-center trial will be conducted in China The overall time to participate in this study is 10 weeks Participants will make multiple visits to the clinic and 28 days after last dose of study drug for a follow-up assessment
The study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Vonoprazan 20 mg
Esomeprazole 20 mg
All participants will be asked to take one tablet in combination with bismuth containing quadruple therapy amoxicillin clarithromycin and bismuth potassium citrate twice at the same time each day throughout the study
This multi-center trial will be conducted in China The overall time to participate in this study is 10 weeks Participants will make multiple visits to the clinic and 28 days after last dose of study drug for a follow-up assessment
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