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

Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106860
• Other study ID #: 04-003
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2005
• Last updated: January 7, 2008
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: January 2008
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• a benzodiazepine drug

Locations

Country	Name	City	State
United States	Future Search Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center	Bradenton	Florida
United States	CNS Research Institute (CRI)	Clementon	New Jersey
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Oregon Center for Clinical Research, Inc.	Eugene	Oregon
United States	Comprehensive Neuroscience of Northern Virginia	Falls Church	Virginia
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Suburban Research Associates	Media	Pennsylvania
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	CNS Research Institute (CRI)	Philadelphia	Pennsylvania
United States	Meridien Research	St. Petersburg	Florida
United States	Neurology and NeuroscienceCenter of Ohio	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Secondary	Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD