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:
Jazz Pharmaceuticals
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00106860
First received: March 31, 2005
Last updated: January 7, 2008
Last verified: January 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Anxiety Disorder |
Drug: a benzodiazepine drug |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Jazz Pharmaceuticals:
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
| Estimated Enrollment: | 158 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106860
Locations
| 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
Investigators
| Study Chair: | Murray Stein, MD | University of California, San Diego |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00106860 History of Changes |
| Other Study ID Numbers: | 04-003 |
| Study First Received: | March 31, 2005 |
| Last Updated: | January 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jazz Pharmaceuticals:
|
Anxiety Generalized Anxiety Disorder |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013