A Post-marketing Surveillance of Pariet Tab. 5 mg to Prevent Gastric and Duodenal Ulcer Associated With Low-aspirin, 100 mg or Less Daily, Administration in Korean Patients With a History of Gastric and Duodenal Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 29
- 主要终点
- Percentage of Participants With Already Known ADRs
研究概览
简要总结
The purpose of this study is to understand the following safety related particulars associated with the use of Pariet Tablet 5 milligram (mg) to prevent gastric and duodenal ulcer from low dose aspirin administration of 100 mg or less daily in participants with a history of gastric and duodenal ulcer: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged over 18 years
- •Participants who have a history of gastric and duodenal ulcer falling under the approved indication for Pariet Tablet 5 mg and who are receiving Pariet Tablet 5 mg to prevent gastric and duodenal ulcer from low dose aspirin use of 100 mg or less daily
- •Participants whose prescription of Pariet Tablet 5 mg has been determined before study participation
- •Participants who have given written consent to the use of their personal and medical information
排除标准
- •Participants with a known hypersensitivity to rabeprazole sodium, any excipients used in the formulation or benzimidazole derivatives, and with the history of such hypersensitivity
- •Participants administered with atazanavir
- •Pregnant or lactating
- •Participants administered with rilpivirine
- •Participants currently participating in other clinical trials
研究组 & 干预措施
Pariet
Participants with gastric and duodenal ulcer being administered with Pariet 5 mg, tablet within the scope of the approved label for Korea under the medical judgment of the investigator will be observed up to maximum of 24 weeks.
干预措施: Pariet (Drug)
结局指标
主要结局
Percentage of Participants With Already Known ADRs
时间窗: Up to Week 24
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADR. Already known ADRs are those listed in product licensure/notification of the drug.
Percentage of Participants with Final Effectiveness Evaluation
时间窗: Up to Week 24
Participants assessed for final effectiveness after first dose of drug will be categorized into four categories: Improved, Unchanged, Worsened, and Unknown.
Percentage of Participants With ADRs
时间窗: Up to Week 24
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADR.
Percentage of Participants With SAEs
时间窗: Up to Week 24
SAEs is defined as any untoward medical occurrence: resulting in death; life threatening condition requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or occurrence of other medically significant events that need treatment such as drug dependency or abuse, blood disease.
Percentage of Participants With Unexpected AEs
时间窗: Up to Week 24
An AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results), symptoms, or diseases occurring during administration of drug, which do not necessarily have a causal relationship with the drug in question. An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug.
Percentage of Participants With Unexpected ADRs
时间窗: Up to Week 24
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug.
Percentage of Participants With Non-serious ADRs
时间窗: Up to Week 24
An ADR is defined as all noxious and unintended responses to a study drug related to any dose. All adverse events in which its causal relationship with the study drug is at least a reasonable possibility will be reported as ADRs.
次要结局
未报告次要终点