Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-03 @ 3:00 PM
Study NCT ID:
NCT03214094
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2017-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Status:
COMPLETED
Status Verified Date:
2020-02
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 survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.
Detailed Description:
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.
This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.
The survey will enroll approximately 1,000 participants.
\- Vonoprazan 10 mg
This multi-center observational survey will be conducted in Japan.
This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.
The survey will enroll approximately 1,000 participants.
\- Vonoprazan 10 mg
This multi-center observational survey will be conducted in Japan.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JapicCTI-163435 | REGISTRY | JapicCTI | View |