A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 19
- 主要终点
- Change in pain scores from baseline to following treatment.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
详细描述
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
T-62 100 mg bid
干预措施: T-62 Dose 1 (Drug)
T-62 200 mg bid
干预措施: T-62 Dose 2 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in pain scores from baseline to following treatment.
时间窗: weekly
次要结局
- General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)(weekly)
- Pharmacokinetics(weekly)
