A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Transient Insomnia
Intervention: Gabapentin (Drug); Gabapentin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on
sleep in subjects with transient insomnia.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Latency to persistent sleep as measured by polysomnography
Secondary outcome: Subjective wake after sleep onsetSubjective total sleep time Subjective assessment of sleep refreshment Subjective assessment of sleep quality Stanford Sleepiness Scale Karolinska Sleep Diary-Sleep (KSD) Quality Index KSD individual scores Digit Symbol Substitution Test Latency to REM sleep Number of awakenings Wake after sleep onset Total wake time plus Stage 1 sleep Total sleep time Sleep efficiency Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) Vital signs Adverse events Sleep onset latency Percent slow wave sleep (Stages 3&4 combined) Subjective sleep latency Subjective number of awakenings
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, Glendale, California 91206, United States
Pfizer Investigational Site, 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
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2004
Last updated: April 23, 2008
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