跳至主要内容
临床试验/NCT00809679
NCT00809679终止2 期

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

Pfizer0 个研究点目标入组 19 人开始时间: 2008年12月最近更新:
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
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

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

Experimental

干预措施: T-62 Dose 1 (Drug)

T-62 200 mg bid

Experimental

干预措施: T-62 Dose 2 (Drug)

Placebo

Placebo Comparator

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)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

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