SPECIAL INVESTIGATION OF LONG TERM USE 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
- 891
- 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 long term use with 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
Patients who fulfill criteria below:
- Patients who have previously enrolled in A0081261.
- Patients who have been administered Lyrica for more than 52 weeks.
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 by Lyrica for over 52 weeks 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: From Week 1 to Week 104 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(From Week 1 to Week 104 at maximum)
- Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert(From Week 1 to Week 104 at maximum)
- Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events(From Week 1 to Week 104 at maximum)
- Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury(From Week 1 to Week 104 at maximum)
- Number of Participants With Adverse Drug Reactions Related to Vision-related Events(From Week 1 to Week 104 at maximum)
- Change From Baseline in Participant-rated Pain Score at Week 104(Baseline and at Week 104)
- Clinical Effectiveness Rate(At Week 104)
- Patient's Impression (PGIC) at Week 104(At Week 104)
- Physician's Impression (CGIC) at Week 104(At Week 104)
- Change From Baseline in Participant-rated Sleep Interference Score at Week 104(Baseline and at Week 104)