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The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin 250 mg | Experimental |
| |
| Gabapentin 500 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 250 mg oral capsule 30 minutes prior to bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to persistent sleep as measured by polysomnography | Hour +8 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective wake after sleep onset | Hour +8 | |
| Subjective total sleep time | Hour +8 | |
| Subjective assessment of sleep refreshment |
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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 | Glendale | California | 91206 | 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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| Gabapentin |
| Drug |
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime |
|
| Placebo | Drug | Matched placebo 30 minutes prior to bedtime |
|
| Hour +8 |
| Subjective assessment of sleep quality | Hour +8 |
| Stanford Sleepiness Scale | Hour +13 |
| Karolinska Sleep Diary-Sleep (KSD) Quality Index | Hour +8 |
| KSD individual scores | Hour +8 |
| Digit Symbol Substitution Test | Hour +8 |
| Latency to REM sleep | Hour +8 |
| Number of awakenings | Hour +8 |
| Wake after sleep onset | Hour +8 |
| Total wake time plus Stage 1 sleep | Hour +8 |
| Total sleep time | Hour +8 |
| Sleep efficiency | Hour +8 |
| Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep | Hour +8 |
| Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) | Hour +8 |
| Vital signs | Hour +8 |
| Adverse events | Hour +13 |
| Sleep onset latency | Hour +8 |
| Percent slow wave sleep (Stages 3&4 combined) | Hour +8 |
| Subjective sleep latency | Hour +8 |
| Subjective number of awakenings | Hour +8 |
| San Diego |
| California |
| 92123 |
| United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66211 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | New York | New York | 10025 | 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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