临床试验/NCT00132119

NCT00132119已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling

Somaxon Pharmaceuticals0 个研究点目标入组 233 人开始时间: 2005年8月最近更新: 2008年5月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 233
主要终点: Assess efficacy in treatment of pathological gambling

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine if nalmefene is safe and effective in the treatment of pathological gambling.

详细描述

Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.

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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

排除标准

未提供

研究组 & 干预措施

1

Experimental

Nalmefene HCl 20 mg

干预措施: nalmefene HCl (Drug)

2

Experimental

Nalmefene HCl 40 mg

干预措施: nalmefene HCl (Drug)

3

Placebo Comparator

Placebo

干预措施: Placebo (Other)

结局指标

主要结局

Assess efficacy in treatment of pathological gambling

次要结局

Evaluate safety and tolerability in treatment of pathological gambling

研究者

发起方

Somaxon Pharmaceuticals

申办方类型

Industry

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