NCT00283842终止3 期
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 408 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 408
- 主要终点
- Change in Mean Pain Severity Score From Baseline to 13 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diabetes type 1 or 2
- •Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
排除标准
- •Major Depression
- •Uncontrolled diabetes
研究组 & 干预措施
desvenlafaxine succinate sustained-release (DVS SR) 50mg
Experimental
干预措施: DVS SR (Drug)
desvenlafaxine succinate sustained-release (DVS SR) 100mg
Experimental
干预措施: DVS SR (Drug)
desvenlafaxine succinate sustained-release (DVS SR) 200mg
Experimental
干预措施: DVS SR (Drug)
desvenlafaxine succinate sustained-release (DVS SR) 400mg
Experimental
干预措施: DVS SR (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Pain Severity Score From Baseline to 13 Weeks
时间窗: Baseline and 13 weeks
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
次要结局
- Number of Patients With ≥50% Reduction in Mean Pain Severity Score.(Baseline and 13 weeks)
研究者
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