POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Number of participants with Adverse Event (AE)
研究概览
简要总结
This is an open-label, non-comparative, non-interventional, prospective, and multi-center PMS study to observe safety and effectiveness of Lyrica CR (82.5mg, 165mg, 330mg) in Korean subjects under the actual condition of use. PMS is an obligation to K-MFDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open-label
This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice.
干预措施: Lyrica CR (Pregabalin) (Drug)
结局指标
主要结局
Number of participants with Adverse Event (AE)
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Duration, severity, outcome and causal relationship of the AE with the study drug (Lyrica CR) will be measured.
Number of participants with Serious Adverse Event (SAE)
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
SAE is any untoward medical occurrence attributed to Lyrica CR in a participant who received the study drug. A serious ADR was an ADR resulting in any of the following outcomes or deemed signification for any other reason: death; life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defects; is an important medical event.
Number of participants with Adverse Drug Reactions (ADRs)
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
All the AEs, except for those with the causal relationship of 'Unlikely', are considered as adverse drug reactions (ADRs)
Percentage of participants with Adverse Drug Reactions (ADRs)
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
All the AEs, except for those with the causal relationship of 'Unlikely', are considered as adverse drug reactions (ADRs)
Percentage of participants with Adverse Event (AE)
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Duration, severity, outcome and causal relationship of the AE with the study drug (Lyrica CR) will be measured.
Percentage of participants with unexpected AEs
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Unexpected AEs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".
Percentage of participants with unexpected ADRs
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Unexpected ADRs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".
Number of participants with unexpected AEs
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Unexpected AEs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".
Number of participants with unexpected ADRs
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Unexpected ADRs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".
Percentage of participants with Serious Adverse Event (SAE)
时间窗: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
SAE is any untoward medical occurrence attributed to Lyrica CR in a participant who received the study drug. A serious ADR was an ADR resulting in any of the following outcomes or deemed signification for any other reason: death; life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defects; is an important medical event.
次要结局
- Severity of pain after administration of Lyrica CR(At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.)
- Sleep interference status after administration of Lyrica CR(At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.)
- Clinician's Global Impression of Change(At the end of the study (At 12 weeks, with window period of 2 weeks))
- Final Effectiveness Evaluation(At the end of the study (At 12 weeks, with window period of 2 weeks))
- Patient's Global Impression of Change (PGIC)(At the end of the study (At 12 weeks, with window period of 2 weeks))