NCT01020526已完成4 期
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.25 个研究点 分布在 3 个国家目标入组 63 人开始时间: 2010年9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
- 63
- 试验地点
- 25
- 主要终点
- Change From Baseline in Pain Numeric Rating Scale by Week
研究概览
简要总结
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
排除标准
- •Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
研究组 & 干预措施
Pregabalin
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
Change From Baseline in Pain Numeric Rating Scale by Week
时间窗: Baseline, Weeks 3, 8, 16, 24 and Last Visit.
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.
次要结局
未报告次要终点
研究者
研究点 (25)
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