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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00163046 |
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, 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, Placebo-Controlled, Multicenter, 28-Day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance |
Enrollment: | 256 |
Study Start Date: | October 2005 |
Study Completion Date: | April 2006 |
Arms | Assigned Interventions |
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Gabapentin: Experimental |
Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
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Placebo: Placebo Comparator |
Drug: Placebo
Matched placebo 30 minutes prior to bedtime for 28 days
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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 | |
Glendale, California, United States, 91206 | |
Pfizer Investigational Site | |
San Diego, California, United States, 92123 | |
United States, Kansas | |
Pfizer Investigational Site | |
Overland Park, Kansas, United States, 66212 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9451155 |
Study First Received: | September 8, 2005 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00163046 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 |