NCT01773993已完成不适用
SPECIAL INVESTIGATION OF PREGABALIN FOR FIBROMYALGIA
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 534 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 主要终点
- Percentage of Participants With Adverse Drug Reaction
研究概览
简要总结
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.
详细描述
All the patients whom an investigator prescribes the first pregabalin 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 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Fibromyalgia
- •Pregabalin naive patient
排除标准
- •Clinical diagnosis of neuropathic pain
研究组 & 干预措施
Pregabalin
Subjects who are treated with pregabalin
干预措施: Pregabalin (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reaction
时间窗: From Week 1 to 52 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(From Week 1 to52 weeks)
- Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert(From Week 1 to 52 weeks)
- Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events(From Week 1 to 52 weeks)
- Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury(From Week 1 to 52 weeks)
- Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks(Baseline and at Week 52)
- Number of Participants With Adverse Drug Reactions Related to Vision-related Events(From Week 1 to 52 weeks)
- Change From Baseline in Pain Score at Week 52(Baseline and at Week 52)
- Physician's Impression (CGIC) at Week 52(At Week 52)
- Change From Baseline in Quality of Sleep Score at Week 52(Baseline and at Week 52)
- Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52(Baseline and at Week 52)
- Patient's Impression (PGIC) at Week 52(At Week 52)
- Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks(At Week 52)
- Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks(At Week 52)
研究者
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