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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00750919 |
This trial is a twenty-six week, open label extension trial to investigate safety and explore efficacy of org 50081in patients with insomnia who completed protocol 21106.
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Drug: Org 50081 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Twenty-Six Weeks, Open-Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106 |
Estimated Enrollment: | 211 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental
Org 50081 one tablet daily
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Drug: Org 50081
4.5 mg tablet / once daily
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
United States, Florida | |
Investigational Site 150 | Recruiting |
Maitland, Florida, United States, 32751 | |
United States, Georgia | |
Investigational Site 151 | Recruiting |
Atlanta, Georgia, United States, 30328 | |
United States, Kentucky | |
Investigational Site 148 | Recruiting |
Crestview Hills, Kentucky, United States, 41017 | |
United States, Massachusetts | |
Investigational Site 138 | Recruiting |
Springfield, Massachusetts, United States, 01107 | |
United States, Pennsylvania | |
Investigational Site 149 | Recruiting |
West Chester, Pennsylvania, United States, 19382 | |
United States, Vermont | |
Investigational Site 139 | Recruiting |
Essex Junction, Vermont, United States, 05452 | |
United States, Virginia | |
Investigational Site 152 | Recruiting |
Richmond, Virginia, United States, 23294 | |
United States, Washington | |
Investigational Site 153 | Recruiting |
Seattle, Washington, United States, 98104 | |
Investigational Site 154 | Recruiting |
Wenatchee, Washington, United States, 98801 | |
Canada | |
Investigational Site 121 | Recruiting |
Toronto, Canada, M9W 4L6 | |
Investigational Site 143 | Recruiting |
Sarnia, Canada, N7T 4X3 | |
Sweden | |
Investigational Site 135 | Recruiting |
Halmstad, Sweden, SE-302 27 | |
Investigational Site 123 | Recruiting |
Göteborg, Sweden, SE-413 45 | |
Investigational Site 134 | Recruiting |
Göteborg, Sweden, SE-412 55 | |
Investigational Site 122 | Recruiting |
Örebro, Sweden, SE-701 85 |
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 176003, P05721 |
Study First Received: | September 10, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00750919 |
Health Authority: | United States: Food and Drug Administration |
Sleep Initiation and Maintenance Disorders Signs and Symptoms Mental Disorders Neurologic Manifestations |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Pathologic Processes Disease Nervous System Diseases |