NCT00106860

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (planned)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anxiety Disorder

Interventions

Type	Name	Description
DRUG	a benzodiazepine drug

Timeline

• Start date: 2005-03-01
• Completion: 2006-03-01
• First posted: 2005-04-01
• Last updated: 2008-01-09

Locations

13 sites across 1 country: United States