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The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 50 mg oral capsule 30 minutes before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications) | Throughout Day 90 | |
| Subject compliance with directions for use (number of capsules per dose and the number of doses per day) | Throughout Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Duration of study |
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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 | Anaheim | California | 92801 | 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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| Bonita |
| California |
| 91902 |
| United States |
| Pfizer Investigational Site | Fallbrook | California | 92028 | United States |
| Pfizer Investigational Site | Hacienda Heights | California | 91746 | United States |
| Pfizer Investigational Site | La Mesa | California | 91942 | United States |
| Pfizer Investigational Site | Oceanside | California | 92054 | United States |
| Pfizer Investigational Site | Orange | California | 92866 | United States |
| Pfizer Investigational Site | San Dimas | California | 91773 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| Pfizer Investigational Site | Weston | Florida | 33326 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21228 | United States |
| Pfizer Investigational Site | Elk River | Minnesota | 55330 | United States |
| Pfizer Investigational Site | Northfield | Minnesota | 55057 | United States |
| Pfizer Investigational Site | Red Wing | Minnesota | 55066 | United States |
| Pfizer Investigational Site | Saint Louis Park | Minnesota | 55426 | United States |
| Pfizer Investigational Site | Holly Springs | Mississippi | 38625 | United States |
| Pfizer Investigational Site | Belton | Missouri | 64012 | United States |
| Pfizer Investigational Site | Independence | Missouri | 64054 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87104 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87110 | United States |
| Pfizer Investigational Site | Taos | New Mexico | 87571 | United States |
| Pfizer Investigational Site | Cary | North Carolina | 27513 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27606 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Pfizer Investigational Site | Houston | Texas | 77088 | United States |
| Pfizer Investigational Site | Pearland | Texas | 77581 | United States |
| Pfizer Investigational Site | Bountiful | Utah | 84010 | United States |
| Pfizer Investigational Site | Ogden | Utah | 84401 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84121 | United States |
| Pfizer Investigational Site | Syracuse | Utah | 84075 | United States |
| Pfizer Investigational Site | West Valley City | Utah | 84120 | United States |
| Pfizer Investigational Site | Falls Church | Virginia | 22041 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23233 | 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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