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"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,304
- 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 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).
详细描述
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.
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 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
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(Up to 12 months)
- Percentage of Participants With Duodenal Ulcers(Up to 12 months)
- Percentage of Participants With Duodenal Hemorrhagic Lesions(Up to 12 months)
- Percentage of Participants With Gastric Hemorrhagic Lesions(Up to 12 months)