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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00236080 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder
Condition | Intervention | Phase |
---|---|---|
Chronic Shift Work Sleep Disorder |
Drug: PROVIGIL |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients With Chronic Shift Work Sleep Disorder |
Estimated Enrollment: | 120 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2005 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
United States, Arizona | |
Psypharma Clinical Research | |
Phoenix, Arizona, United States, 85050 | |
PsyPharma Clinical Tucson | |
Tucson, Arizona, United States, 85712 | |
United States, Arkansas | |
Central Arkansas Research | |
Hot Springs, Arkansas, United States, 71913 | |
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
Pacific Sleep Medicine Service | |
San Diego, California, United States, 92121 | |
Pacific Sleep Medicine Service | |
Los Angeles, California, United States, 90048 | |
BMR HealthQuest | |
San Diego, California, United States, 92123 | |
United States, Georgia | |
Neurotrials Research | |
Atlanta, Georgia, United States, 30342 | |
SLEEPMED, Inc. | |
Macon, Georgia, United States, 31202 | |
United States, Illinois | |
Henry Lahmeyer, MD | |
Northfield, Illinois, United States, 60093 | |
United States, Kansas | |
Vince and Associates Clinical | |
Overland Park, Kansas, United States, 66211 | |
United States, Maryland | |
Center for Sleep/Wake Disorder | |
Chevy Chase, Maryland, United States, 20815 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Nevada | |
Clinical Rsch Center of Nevada | |
Las Vegas, Nevada, United States, 89104 | |
United States, New York | |
Clinilabs / Sleep Disorders In | |
New York, New York, United States, 10025 | |
United States, North Carolina | |
Wake Research Associates | |
Raleigh, North Carolina, United States, 27612 | |
United States, Ohio | |
St. Vincent Mercy Medical Cent | |
Toledo, Ohio, United States, 43608 | |
United States, Pennsylvania | |
Consolidated Clinical Trials | |
Pittsburgh, Pennsylvania, United States, 15221 | |
United States, South Carolina | |
SleepMed of South Carolina | |
Columbia, South Carolina, United States, 29201 | |
United States, Utah | |
Radiant Research Salt Lake | |
Salt Lake City, Utah, United States, 84107 |
Study Director: | Gwendolyn Neibler, DO | Cephalon |
Study ID Numbers: | C10953/3045/ES/US |
Study First Received: | October 7, 2005 |
Last Updated: | July 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00236080 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Sleep Disorders, Circadian Rhythm Mental Disorders Neurologic Manifestations Disorders of Environmental Origin |
Dyssomnias Sleep Disorders Occupational Diseases Chronobiology Disorders Modafinil |
Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Stimulants Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |