Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,366
- 主要终点
- Frequency of 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 lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
详细描述
This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin.
The usual adult dosage is 15 mg of lansoprazole administered orally once daily.
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
- •(1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)
排除标准
- •(1) Patients with gastric or duodenal ulcer (in the active [A1, A2] or healing [H1, H2] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole
研究组 & 干预措施
Lansoprazole 15 mg
Lansoprazole 15 mg orally once daily
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Frequency of Adverse Drug Reactions
时间窗: 12 months
Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
次要结局
- Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion(From baseline to 12 months)
- Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions(From baseline to 12 months)
- Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions(From baseline to 12 months)
- Presence or Absence of Endoscopic Examinations(From baseline to 12 months)
- Presence of Gastric or Duodenal Hemorrhagic Lesion(From baseline to 12 months)
- Treatment for Gastric/Duodenal Ulcer or Lesion(From baseline to 12 months)
- Presence of Gastric or Duodenal Ulcer(From baseline to 12 months)