A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 294
- 主要终点
- Change From Baseline in the Average Pain Intensity Score at Week 12
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.
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
- Double (Participant, Investigator)
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
- •Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash
排除标准
- •Female patients with reproductive potential
- •Active herpes zoster skin rash
- •Current or anticipated treatment with acupuncture, TNS, or steroids
- •Current or anticipated use of topical analgesic agents with PHN
- •Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
研究组 & 干预措施
AGN-214868 3.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
干预措施: AGN-214868 (Drug)
AGN-214868 16.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
干预措施: AGN-214868 (Drug)
Placebo
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
干预措施: Placebo to AGN-214868 (Drug)
结局指标
主要结局
Change From Baseline in the Average Pain Intensity Score at Week 12
时间窗: Baseline, Week 12
Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
次要结局
- Change From Baseline in Area of Spontaneous Pain(Baseline, Week 12)
- Change From Baseline in Area of Allodynia(Baseline, Week 12)
- Change From Baseline in Evoked Pain Score in the Area of Allodynia(Baseline, Week 12)