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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00666575 |
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
Condition | Intervention | Phase |
---|---|---|
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, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population |
Estimated Enrollment: | 2105 |
Study Start Date: | December 2004 |
Study Completion Date: | May 2005 |
Arms | Assigned Interventions |
---|---|
Gabapentin: Experimental |
Drug: Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
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Placebo: Placebo Comparator |
Drug: Placebo
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Pfizer Investigational Site | |
Mobile, Alabama, United States, 36608 | |
United States, Arizona | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85018 | |
United States, California | |
Pfizer Investigational Site | |
Beverly Hills, California, United States, 90211 | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94102 | |
United States, Florida | |
Pfizer Investigational Site | |
West Palm Beach, Florida, United States, 33409 | |
Pfizer Investigational Site | |
New Port Richey, Florida, United States, 34652 | |
Pfizer Investigational Site | |
Pembroke Pines, Florida, United States, 33024 | |
Pfizer Investigational Site | |
Deland, Florida, United States, 32720 | |
Pfizer Investigational Site | |
Clearwater, Florida, United States, 33765 | |
United States, Georgia | |
Pfizer Investigational Site | |
Atlanta, Georgia, United States, 30328 | |
United States, Idaho | |
Pfizer Investigational Site | |
Boise, Idaho, United States, 83704 | |
Pfizer Investigational Site | |
Boise, Idaho, United States, 83712 | |
United States, Indiana | |
Pfizer Investigational Site | |
Indianapolis, Indiana, United States, 46250 | |
United States, Nevada | |
Pfizer Investigational Site | |
Las Vegas, Nevada, United States, 89104 | |
Pfizer Investigational Site | |
Las Vegas, Nevada, United States, 89128 | |
United States, New Mexico | |
Pfizer Investigational Site | |
Santa Fe, New Mexico, United States, 87505 | |
United States, Tennessee | |
Pfizer Investigational Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Pfizer Investigational Site | |
Austin, Texas, United States, 78705 | |
Pfizer Investigational Site | |
Fort Worth, Texas, United States, 76135 | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78205 | |
Pfizer Investigational Site | |
SAN ANTONIO, Texas, United States, 78229 | |
United States, Utah | |
Pfizer Investigational Site | |
Salt Lake City, Utah, United States, 84102 | |
Pfizer Investigational Site | |
West Jordan, Utah, United States, 84088 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9451146 |
Study First Received: | April 23, 2008 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00666575 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 |