Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753437
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2021-02-12
Brief Title:
A Study of Vonoprazan in Adults With Helicobacter Pylori
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Double-Blind Parallel Group Study to Evaluate the Safety Tolerability and Pharmacokinetics of Quadruple Therapy Bismuth Clarithromycin and Amoxicillin With Vonoprazan Versus Quadruple Therapy With Esomeprazole
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:
Helicobacter Pylori H Pylori is a bug found in the digestive system It can cause soreness and redness in the stomach gastritis It can also cause ulcers in the stomach and other parts of the digestive system Vonoprazan is a medicine to treat people with H Pylori It is taken together with other medicines to fight infections caused by H Pylori
The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body It will be compared with another medicine called esomeprazole Other aims are to check for side effects from the study medicines
At the first visit the study doctor will check who can take part Participants who take part will be picked for 1 of 2 treatments by chance
Vonoprazan taken with bismuth clarithromycin and amoxicillin
Esomeprazole taken with bismuth clarithromycin and amoxicillin
Both treatments will last for 14 days Participants will stay in the clinic throughout their treatment
After treatment the clinic staff will telephone the participants 2 days later for a check-up The participants will visit the clinic 4 weeks later for a final check-up
The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body It will be compared with another medicine called esomeprazole Other aims are to check for side effects from the study medicines
At the first visit the study doctor will check who can take part Participants who take part will be picked for 1 of 2 treatments by chance
Vonoprazan taken with bismuth clarithromycin and amoxicillin
Esomeprazole taken with bismuth clarithromycin and amoxicillin
Both treatments will last for 14 days Participants will stay in the clinic throughout their treatment
After treatment the clinic staff will telephone the participants 2 days later for a check-up The participants will visit the clinic 4 weeks later for a final check-up
Detailed Description:
This is a study in healthy participants with Helicobacter pylori HP positive to evaluate the safety tolerability and PK of a quadruple therapy with bismuth clarithromycin amoxicillin and vonoprazan versus quadruple therapy with bismuth clarithromycin amoxicillin and esomeprazole
The treatment phase consists of quadruple therapy twice daily BID with bismuth potassium citrate 600 mg clarithromycin 500 mg amoxicillin 1000 mg and vonoprazan 20 mg Group B or quadruple therapy BID with bismuth potassium citrate 600 mg clarithromycin 500 mg amoxicillin 1000 mg and esomeprazole 20 mg Group A from Days 1 to 14 Participants will be discharged on Day 15 after all procedures have been performed
This single-center will be conducted in China Participants will remain confined to the study site from check-in Day -1 through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment
The treatment phase consists of quadruple therapy twice daily BID with bismuth potassium citrate 600 mg clarithromycin 500 mg amoxicillin 1000 mg and vonoprazan 20 mg Group B or quadruple therapy BID with bismuth potassium citrate 600 mg clarithromycin 500 mg amoxicillin 1000 mg and esomeprazole 20 mg Group A from Days 1 to 14 Participants will be discharged on Day 15 after all procedures have been performed
This single-center will be conducted in China Participants will remain confined to the study site from check-in Day -1 through Day 15 and will followed up through call on Day 17 and return on Day 42 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1257-0258 | REGISTRY | WHO | None |