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"

Takeda1,304 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

1,304

Conditions

A History of 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 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

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

The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers.

Time frame: Up to 12 months

Percentage of Participants With Duodenal Ulcers

The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers.

Time frame: Up to 12 months

Percentage of Participants With Gastric Hemorrhagic Lesions

The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions.

Time frame: Up to 12 months

Percentage of Participants With Duodenal Hemorrhagic Lesions

The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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