NCT03214094

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

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
• Phase: —
• Study type: Observational
• Enrollment: 1,119 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric or Duodenal Ulcers

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonoprazan tablets

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-02-28
• Completion: 2019-02-28
• First posted: 2017-07-11
• Last updated: 2020-03-11
• Results posted: 2020-03-11

Locations

1 site across 1 country: Japan