DRUG USE INVESTIGATION OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,827
- 主要终点
- Percentage of Participants With Adverse Drug Reaction
研究概览
简要总结
The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
详细描述
All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be administered Lyrica® in order to be enrolled in the surveillance.
排除标准
- •Patients not administered Lyrica®.
研究组 & 干预措施
Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule".
干预措施: Pregabalin (Lyrica) capsule (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reaction
时间窗: 13 weeks at maximum
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.
次要结局
- Percentage of Participants With Serious Adverse Drug Reaction(13 weeks at maximum)
- The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert(13 weeks at maximum)
- Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events(13 weeks at maximum)
- Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury(13 weeks at maximum)
- Number of Participants With Adverse Drug Reactions Related to Vision-related Events(13 weeks at maximum)
- Clinical Effectiveness Rate(At Week 13)
- Change From Baseline in Participant-rated Pain Score at Week 13(Baseline and at Week 13)
- Physician's Impression (CGIC) at Week 13(At Week 13)
- Patient's Impression (PGIC) at Week 13(At Week 13)
- Change From Baseline in Participant-rated Sleep Interference Score at Week 13(Baseline and at Week 13)