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"

Takeda

Status: Completed

Conditions: A History of Gastric or Duodenal Ulcers

Treatments: Drug: Vonoprazan

Study type: Observational

Funder types: Industry

Identifiers

NCT03214198

JapicCTI-163436 (Registry Identifier)

Vonoprazan-5005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,304 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a history of gastric or duodenal ulcer

Exclusion criteria

• Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
• Participants with active upper gastrointestinal haemorrhage at initiation of vonoprazan therapy
• Participants with a history of hypersensitivity to any ingredients of vonoprazan Tablets
• Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Trial design

1,304 participants in 1 patient group

Vonoprazan 10 mg

Description:

The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.

Treatment:

Drug: Vonoprazan