NCT03214198

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,304 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

Detailed description

The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers. This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs. The study will enroll approximately 1000 participants. • Vonoprazan 10 mg This multi-center observational survey will be conducted in Japan.

Conditions

• A History of Gastric or Duodenal Ulcers

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonoprazan tablets

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2017-07-11
• Last updated: 2023-06-07
• Results posted: 2021-05-19

Locations

1 site across 1 country: Japan