Clinical trial NCT00666770: A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transient Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.


Eligibility criteria: 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

Primary outcomes:
measure: Latency to persistent sleep as measured by polysomnography
timeFrame: Hour +8
Secondary outcomes:
measure: Subjective wake after sleep onset
timeFrame: Hour +8
measure: Subjective total sleep time
timeFrame: Hour +8
measure: Subjective assessment of sleep refreshment
timeFrame: Hour +8
measure: Subjective assessment of sleep quality
timeFrame: Hour +8
measure: Stanford Sleepiness Scale
timeFrame: Hour +13
measure: Karolinska Sleep Diary-Sleep (KSD) Quality Index
timeFrame: Hour +8
measure: KSD individual scores
timeFrame: Hour +8
measure: Digit Symbol Substitution Test
timeFrame: Hour +8
measure: Latency to REM sleep
timeFrame: Hour +8
measure: Number of awakenings
timeFrame: Hour +8
measure: Wake after sleep onset
timeFrame: Hour +8
measure: Total wake time plus Stage 1 sleep
timeFrame: Hour +8
measure: Total sleep time
timeFrame: Hour +8
measure: Sleep efficiency
timeFrame: Hour +8
measure: Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep
timeFrame: Hour +8
measure: Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
timeFrame: Hour +8
measure: Vital signs
timeFrame: Hour +8
measure: Adverse events
timeFrame: Hour +13
measure: Sleep onset latency
timeFrame: Hour +8
measure: Percent slow wave sleep (Stages 3&4 combined)
timeFrame: Hour +8
measure: Subjective sleep latency
timeFrame: Hour +8
measure: Subjective number of awakenings
timeFrame: Hour +8
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: