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

January 7, 2008 updated by: Jazz Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • Study Chair: Murray Stein, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

March 31, 2005

First Submitted That Met QC Criteria

March 31, 2005

First Posted (Estimate)

April 1, 2005

Study Record Updates

Last Update Posted (Estimate)

January 9, 2008

Last Update Submitted That Met QC Criteria

January 7, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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