Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00106860
First received: March 31, 2005
Last updated: January 7, 2008
Last verified: January 2008
History of Changes

March 31, 2005
January 7, 2008
March 2005
 
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)
Same as current
Complete list of historical versions of study NCT00106860 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
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)

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.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anxiety Disorder
Drug: a benzodiazepine drug
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
March 2006
 

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106860
04-003
 
 
Jazz Pharmaceuticals
 
Study Chair: Murray Stein, MD University of California, San Diego
Jazz Pharmaceuticals
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP