A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance | RxWiki

A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
Condition	Transient Insomnia
Intervention	Drug: Gabapentin Drug: Gabapentin Drug: Placebo
Phase	Phase 3
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00666770
First Received	April 23, 2008
Last Updated	April 23, 2008
Last verified	April 2008

Tracking Information[ + expand ][ + ]

First Received Date	April 23, 2008
Last Updated Date	April 23, 2008
Start Date	October 2004
Estimated Primary Completion Date	November 2004
Current Primary Outcome Measures	Latency to persistent sleep as measured by polysomnography [Time Frame: Hour +8] [Designated as safety issue: No]
Current Secondary Outcome Measures	Subjective wake after sleep onset [Time Frame: Hour +8] [Designated as safety issue: No] Subjective total sleep time [Time Frame: Hour +8] [Designated as safety issue: No] Subjective assessment of sleep refreshment [Time Frame: Hour +8] [Designated as safety issue: No] Subjective assessment of sleep quality [Time Frame: Hour +8] [Designated as safety issue: No] Stanford Sleepiness Scale [Time Frame: Hour +13] [Designated as safety issue: No] Karolinska Sleep Diary-Sleep (KSD) Quality Index [Time Frame: Hour +8] [Designated as safety issue: No] KSD individual scores [Time Frame: Hour +8] [Designated as safety issue: No] Digit Symbol Substitution Test [Time Frame: Hour +8] [Designated as safety issue: No] Latency to REM sleep [Time Frame: Hour +8] [Designated as safety issue: No] Number of awakenings [Time Frame: Hour +8] [Designated as safety issue: No] Wake after sleep onset [Time Frame: Hour +8] [Designated as safety issue: No] Total wake time plus Stage 1 sleep [Time Frame: Hour +8] [Designated as safety issue: No] Total sleep time [Time Frame: Hour +8] [Designated as safety issue: No] Sleep efficiency [Time Frame: Hour +8] [Designated as safety issue: No] Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep [Time Frame: Hour +8] [Designated as safety issue: No] Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) [Time Frame: Hour +8] [Designated as safety issue: No] Vital signs [Time Frame: Hour +8] [Designated as safety issue: Yes] Adverse events [Time Frame: Hour +13] [Designated as safety issue: Yes] Sleep onset latency [Time Frame: Hour +8] [Designated as safety issue: No] Percent slow wave sleep (Stages 3&4 combined) [Time Frame: Hour +8] [Designated as safety issue: No] Subjective sleep latency [Time Frame: Hour +8] [Designated as safety issue: No] Subjective number of awakenings [Time Frame: Hour +8] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Transient Insomnia
Intervention	Drug: Gabapentin Gabapentin 250 mg oral capsule 30 minutes prior to bedtime Drug: Gabapentin Gabapentin 500 mg oral capsule 30 minutes prior to bedtime Drug: Placebo Matched placebo 30 minutes prior to bedtime
Study Arm (s)	Experimental: Gabapentin 250 mg Experimental: Gabapentin 500 mg Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	309
Estimated Completion Date	November 2004
Estimated Primary Completion Date	Not Provided
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00666770
Other Study ID Numbers	A9451139
Has Data Monitoring Committee	No
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	April 2008

Locations[ + expand ][ + ]

Pfizer Investigational Site	Glendale, California, United States, 91206
Pfizer Investigational Site	San Diego, California, United States, 92123
Pfizer Investigational Site	Overland Park, Kansas, United States, 66211
Pfizer Investigational Site	Overland Park, Kansas, United States, 66212
Pfizer Investigational Site	New York, New York, United States, 10025