NCT00533351终止2 期
Safety and Efficacy of AGN201781 in Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 9
- 主要终点
- Change From Baseline in Daily Pain Score at Week 2
研究概览
简要总结
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
- •Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia
排除标准
- •Women of child-bearing potential
- •Any other uncontrolled diseases
研究组 & 干预措施
AGN201781
Experimental
AGN201781 50 mg capsules three-time daily for 2 weeks
干预措施: AGN201781 (Drug)
Placebo
Placebo Comparator
placebo 50 mg capsules three-times daily for 2 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Daily Pain Score at Week 2
时间窗: Baseline, Week 2
Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed
次要结局
- Change From Baseline in Subject Global Impression of Change Score at Week 2(Baseline, Week 2)
研究者
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