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

Primary Purpose

Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
a benzodiazepine drug
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder focused on measuring Anxiety, Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Florida Clinical Research Center
  • Clinical Neuroscience Solutions, Inc.
  • Meridien Research
  • CNS Research Institute (CRI)
  • Midwest Clinical Research Center
  • Neurology and NeuroscienceCenter of Ohio
  • IPS Research Company
  • Oregon Center for Clinical Research, Inc.
  • Suburban Research Associates
  • CNS Research Institute (CRI)
  • Future Search Trials
  • Comprehensive Neuroscience of Northern Virginia
  • Northwest Clinical Research Center

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
March 31, 2005
Last Updated
January 7, 2008
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00106860
Brief Title
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Official Title
A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Anxiety, Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
158 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
a benzodiazepine drug
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
Title
Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray Stein, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
Florida Clinical Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
CNS Research Institute (CRI)
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Neurology and NeuroscienceCenter of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oregon Center for Clinical Research, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19603
Country
United States
Facility Name
CNS Research Institute (CRI)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Future Search Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Comprehensive Neuroscience of Northern Virginia
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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