NCT00151528已完成3 期
A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.94 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 428
- 试验地点
- 94
- 主要终点
- Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
研究概览
简要总结
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
- •Must 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 A0081056 which was determined to be related to the study medication by the investigator or the sponsor.
结局指标
主要结局
Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
次要结局
- There are no secondary outcome measures
研究者
研究点 (94)
Loading locations...
相似试验
已完成
3 期
This Study is An Open-Label Trial Of Pregabalin In Patients With FibromyalgiaFibromyalgiaNCT00346034Pfizer's Upjohn has merged with Mylan to form Viatris Inc.357
已完成
3 期
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic PainSpinal Cord DiseasesSpinal Cord InjuriesNeuralgiaPainNCT01202227Pfizer's Upjohn has merged with Mylan to form Viatris Inc.104
已完成
3 期
Pregabalin Open-Label Extension Trial in Patients With Partial SeizuresEpilepsies, PartialEpilepsy, Complex PartialNCT00143143Pfizer300
已完成
3 期
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral NeuropathyDiabetic Neuropathy, PainfulNCT00553280Pfizer's Upjohn has merged with Mylan to form Viatris Inc.123
已完成
4 期
Pregabalin In Adolescent Patients With FibromyalgiaFibromyalgiaNCT01020526Pfizer's Upjohn has merged with Mylan to form Viatris Inc.63