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

Takeda

Status: Completed

Conditions: Gastric or Duodenal Ulcers

Treatments: Drug: Vonoprazan

Study type: Observational

Funder types: Industry

Identifiers

NCT03214094

JapicCTI-163435 (Registry Identifier)

Vonoprazan-5004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,119 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 hemorrhage at initiation vonoprazan therapy
• Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
• Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Trial design

1,119 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