此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

2008年1月7日更新者：Jazz Pharmaceuticals

A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)

The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.

研究概览

地位

完全的

条件

焦虑症

干预/治疗

药品：a benzodiazepine drug

详细说明

This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.

研究类型

介入性

注册

158

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Florida
  - Bradenton、Florida、美国、34208
    - Florida Clinical Research Center
  - Jacksonville、Florida、美国、32216
    - Clinical Neuroscience Solutions, Inc.
  - St. Petersburg、Florida、美国、33709
    - Meridien Research
- New Jersey
  - Clementon、New Jersey、美国、08021
    - CNS Research Institute (CRI)
- Ohio
  - Dayton、Ohio、美国、45408
    - Midwest Clinical Research Center
  - Toledo、Ohio、美国、43623
    - Neurology and NeuroscienceCenter of Ohio
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73103
    - IPS Research Company
- Oregon
  - Eugene、Oregon、美国、97401
    - Oregon Center for Clinical Research, Inc.
- Pennsylvania
  - Media、Pennsylvania、美国、19603
    - Suburban Research Associates
  - Philadelphia、Pennsylvania、美国、19149
    - CNS Research Institute (CRI)
- Texas
  - Austin、Texas、美国、78756
    - Future Search Trials
- Virginia
  - Falls Church、Virginia、美国、22041
    - Comprehensive Neuroscience of Northern Virginia
- Washington
  - Bellevue、Washington、美国、98004
    - Northwest Clinical Research Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Complete Study 04-001-01
Able to take the medication for 9 months
Understand and sign the Informed Consent
Comply with all study-related procedures
Women of child bearing potential must have a confirmed negative urine pregnancy test
Lack of clinically significant abnormalities in health

Exclusion Criteria:

Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
Early termination from study 04-001-01
Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：非随机化
介入模型：单组作业
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量
Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)

次要结果测量

结果测量
Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jazz Pharmaceuticals

调查人员

学习椅：Murray Stein, MD、University of California, San Diego

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年3月1日

研究完成

2006年3月1日

研究注册日期

首次提交

2005年3月31日

首先提交符合 QC 标准的