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

Takeda1,119 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,119

Conditions

Gastric or Duodenal Ulcers

Interventions

VonoprazanDRUG

Vonoprazan tablets

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Takeda Selected Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of Participants Who Had One or More Adverse Drug Reactions

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Time frame: Up to 12 months

Secondary Outcomes

Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets

Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.

Time frame: Up to 12 months

Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets

Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.

Time frame: Up to 12 months

Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets

Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.

Time frame: Up to 12 months

Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets

Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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