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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse and Blood Pressure | Day 45 | |
| Subjective proportion of nights having difficulty sleeping | Day 45 | |
| Subjective Sleep Latency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Drug |
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days |
|
| Day 45 |
| Subjective Wake After Sleep Onset | Day 45 |
| Subjective Number of Awakenings | Day 45 |
| Subjective Total Sleep Time | Day 45 |
| Subjective Assessment of Sleep Quality | Day 45 |
| Subjective Assessment of Ease of Awakening | Day 45 |
| Subject Global Evaluation | Day 45 |
| Pittsburg Sleep Quality Index | Day 45 |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Pfizer Investigational Site | Beverly Hills | California | 90211 | United States |
| Pfizer Investigational Site | San Francisco | California | 94102 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33765 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | New Port Richey | Florida | 34652 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83704 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83712 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89104 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Pfizer Investigational Site | Santa Fe | New Mexico | 87505 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76135 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78205 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84102 | United States |
| Pfizer Investigational Site | West Jordan | Utah | 84088 | United States |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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