A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
- Registration Number
- NCT00667108
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 784
Inclusion Criteria
- Aged >/= 18 years
- Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
Exclusion Criteria
- Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- Recreational drug use within past 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gabapentin 250 mg Gabapentin - Placebo Placebo - Gabapentin 500 mg Gabapentin -
- Primary Outcome Measures
Name Time Method Subjective sleep latency Hour +8
- Secondary Outcome Measures
Name Time Method Subjective assessment of sleep quality Hour +8 Vital signs Hour +8 Adverse events Hour +13 Subjective wake after sleep onset Hour +8 Subjective assessment of sleep refreshment Hour +8 KSD individual scores Hour +8 Digit Symbol Substitution Test Hour +8 Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) Hour +8 Stanford Sleepiness Scale Hour +13 Subjective number of awakenings Hour +8 Subjective total sleep time Hour +8 Karolinska Sleep Diary-Sleep (KSD) Quality Index Hour +8
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Dallas, Texas, United States