NCT00424892已完成2 期
A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
Wyeth is now a wholly owned subsidiary of Pfizer59 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2007年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 59
- 主要终点
- The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
研究概览
简要总结
The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.
详细描述
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
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
- •Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
- •Women of childbearing potential must have a negative serum pregnancy test result at study start.
排除标准
- •Presence of any new/and or clinically important medical condition that might compromise patient's safety.
- •Use of prohibited treatment.
- •Meets any of the exclusion criteria listed for study 3151A4-327.
结局指标
主要结局
The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
次要结局
- Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
研究者
研究点 (59)
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