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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00667108 |
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.
Condition | Intervention | Phase |
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Transient Insomnia |
Drug: Gabapentin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance |
Enrollment: | 784 |
Study Start Date: | October 2004 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
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Gabapentin 250 mg: Experimental |
Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
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Gabapentin 500 mg: Experimental |
Drug: Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
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Placebo: Placebo Comparator |
Drug: Placebo
Matched placebo 30 minutes prior to bedtime
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
San Diego, California, United States, 92121 | |
Pfizer Investigational Site | |
Anaheim, California, United States, 92801 | |
United States, Florida | |
Pfizer Investigational Site | |
Orlando, Florida, United States, 32809 | |
United States, Idaho | |
Pfizer Investigational Site | |
Boise, Idaho, United States, 83704 | |
United States, New Jersey | |
Pfizer Investigational Site | |
Mt. Laurel, New Jersey, United States, 08054 | |
United States, Ohio | |
Pfizer Investigational Site | |
Cincinnati, Ohio, United States, 45219 | |
United States, South Carolina | |
Pfizer Investigational Site | |
Spartanburg, South Carolina, United States, 29307 | |
United States, Texas | |
Pfizer Investigational Site | |
Dallas, Texas, United States, 75235 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9451140 |
Study First Received: | April 23, 2008 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00667108 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sleep Initiation and Maintenance Disorders Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Psychotropic Drugs Central Nervous System Depressants Sleep Disorders Dyssomnias Calcium Channel Blockers |
Cardiovascular Agents Antimanic Agents Sleep Disorders, Intrinsic Calcium, Dietary Mental Disorders Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Sleep Disorders Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Sleep Disorders, Intrinsic Membrane Transport Modulators Sensory System Agents Mental Disorders |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Nervous System Diseases Dyssomnias Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |