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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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A History of Gastric or Duodenal Ulcers

Intervention / Treatment
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* Drug: Vonoprazan


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vonoprazan 10 mg<br>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. | Drug: Vonoprazan<br>* Vonoprazan tablets<br>* Other names: TAK-438;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 12 months |