Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,175
- 主要终点
- Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
研究概览
简要总结
This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
详细描述
continuous patients with target disorders in collaborating institutions
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration
排除标准
- •Non-consenting
- •Hypersensitivity to the active substance or to any of the excipients
- •galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
研究组 & 干预措施
Epilepsy
干预措施: pregabalin (Lyrica) (Drug)
Neuropathic Pain
干预措施: pregabalin (Lyrica) (Drug)
Fibromyalgia
干预措施: pregabalin (Lyrica) (Drug)
结局指标
主要结局
Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
时间窗: Baseline through Week 12
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population
时间窗: Baseline through Week 12
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.
Percentage of Participants With Improvement in Seizure Frequency in ITT Population
时间窗: Baseline through Week 12
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.
Percentage of Participants With Improvement in Seizure Frequency in PP Population
时间窗: Baseline through Week 12
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.
Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
时间窗: Baseline and Week 6
Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
时间窗: Baseline and Week 6
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
时间窗: Baseline and Week 6
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
时间窗: Baseline and Week 6
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.
次要结局
- Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population(Week 6)
- Number of Participants With CGIC Scale for NeP in PP Population(Week 6)
- Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6(Baseline and Week 6)
- Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6(Baseline and Week 6)
- Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6(Baseline and Week 6)
- Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6(Baseline and Week 6)
- Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population(Week 6)
- Number of Participants With PGIC Scale for NeP in PP Population(Week 6)
- Number of Participants With CGIC Scale for Fibromyalgia in ITT Population(Week 6)
- Number of Participants With CGIC Scale for Fibromyalgia in PP Population(Week 6)
- Number of Participants With PGIC Scale for Fibromyalgia in ITT Population(Week 6)
- Number of Participants With PGIC Scale for Fibromyalgia in PP Population(Week 6)