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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Special Drug Use Surveillance of Takecab Tablets for Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use

Conditions
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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 hemorrhage at initiation vonoprazan therapy Participants with a history of hypersensitivity to any ingredients in 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 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. | 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. | 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. | 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. | Up to 12 months |