A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 3 Fixed Doses of EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2004年1月1日最近更新: 2013年2月21日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. It is a selective antagonist that binds competitively to the glutamate site of the N-methyl-D-aspartate (NMDA) receptor.

This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with placebo in subjects with neuropathic pain associated with diabetic 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: Double

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

•Women of childbearing potential must have a negative serum pregnancy test result at screening
•Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet
•Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy

排除标准

•Pregnancy, lactation, or plans to become pregnant during the study
•Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control
•History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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