Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,119
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Had One or More Adverse Drug Reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a history of gastric or duodenal ulcer
排除标准
- •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
研究组 & 干预措施
Vonoprazan 10 mg
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.
干预措施: Vonoprazan (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Drug Reactions
时间窗: Up to 12 months
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.
次要结局
- Percentage of Participants With 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(Up to 12 months)
- Percentage of Participants With 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(Up to 12 months)