A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 25
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
次要结局
- Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD
- Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD