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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106860
Recruitment Status : Completed
First Posted : April 1, 2005
Last Update Posted : January 9, 2008
Information provided by:
Jazz Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Drug: a benzodiazepine drug Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)
Study Start Date : March 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
  2. Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106860

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United States, Florida
Florida Clinical Research Center
Bradenton, Florida, United States, 34208
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Meridien Research
St. Petersburg, Florida, United States, 33709
United States, New Jersey
CNS Research Institute (CRI)
Clementon, New Jersey, United States, 08021
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
Neurology and NeuroscienceCenter of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Oregon Center for Clinical Research, Inc.
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19603
CNS Research Institute (CRI)
Philadelphia, Pennsylvania, United States, 19149
United States, Texas
Future Search Trials
Austin, Texas, United States, 78756
United States, Virginia
Comprehensive Neuroscience of Northern Virginia
Falls Church, Virginia, United States, 22041
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Jazz Pharmaceuticals
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Study Chair: Murray Stein, MD University of California, San Diego

Layout table for additonal information Identifier: NCT00106860     History of Changes
Other Study ID Numbers: 04-003
First Posted: April 1, 2005    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: January 2008
Keywords provided by Jazz Pharmaceuticals:
Generalized Anxiety Disorder
Additional relevant MeSH terms:
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Anxiety Disorders
Pathologic Processes
Mental Disorders