NCT01020474已完成4 期
A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.35 个研究点 分布在 4 个国家目标入组 107 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 35
- 主要终点
- Change From Baseline to Week 15 in Mean Pain Diary Score
研究概览
简要总结
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia
- •12-17 years of age
排除标准
- •Patients with other pain conditions
- •Previous treatment with pregabalin
- •Patients taking excluded medication
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
drug-pregabalin
Experimental
干预措施: pregabalin (Lyrica) (Drug)
结局指标
主要结局
Change From Baseline to Week 15 in Mean Pain Diary Score
时间窗: Week 15
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
次要结局
- Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)(Baseline to Week 15)
- Change From Baseline to Week 15 in Mean Sleep Quality Diary Score(Week 15)
- Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)(Baseline to Week 15)
- Proportion of Patient Global Impression Change (PGIC) at Week 15(Week 15)
- Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)(Week 15)
- Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15(Week 15)
- Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15(Week 15)
研究者
研究点 (35)
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