A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia | RxWiki

A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
Condition	Transient Insomnia
Intervention	Drug: Gabapentin Drug: Gabapentin Drug: Placebo
Phase	Phase 3
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00674752
First Received	May 6, 2008
Last Updated	April 22, 2011
Last verified	April 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 6, 2008
Last Updated Date	April 22, 2011
Start Date	March 2006
Estimated Primary Completion Date	August 2006
Current Primary Outcome Measures	Wake after sleep onset as measured by polysomnography (PSG) [Time Frame: Hour +8] [Designated as safety issue: No]
Current Secondary Outcome Measures	PSG Latency to Persistent Sleep [Time Frame: Hour +8] [Designated as safety issue: No] PSG Wake Time During Sleep [Time Frame: Hour +8] [Designated as safety issue: No] PSG WASO [Time Frame: Hour +8] [Designated as safety issue: No] PSG Sleep Onset Latency [Time Frame: Hour +8] [Designated as safety issue: No] Vital signs [Time Frame: Hour +8] [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] PSG NA [Time Frame: Hour +8] [Designated as safety issue: No] Adverse events [Time Frame: Hour +13] [Designated as safety issue: Yes] PSG Total wake time plus Stage 1 sleep [Time Frame: Hour +8] [Designated as safety issue: No] PSG TST [Time Frame: Hour +8] [Designated as safety issue: No] PSG Sleep Efficiency [Time Frame: Hour +8] [Designated as safety issue: No] PSG Percent of Stages 1, 2, 3, 4 and REM sleep [Time Frame: Hour +8] [Designated as safety issue: No] PSG 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 (NA) [Time Frame: Hour +8] [Designated as safety issue: No] subjective Wake After Sleep Onset (WASO) [Time Frame: Hour +8] [Designated as safety issue: No] subjective Total Sleep Time (TST) [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]

Descriptive Information[ + expand ][ + ]

Brief Title	A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
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 on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
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 oral capsule 30 minutes prior to bedtime
Study Arm (s)	Experimental: A Experimental: B Placebo Comparator: C

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	377
Estimated Completion Date	August 2006
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: - Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening - 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) - Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00674752
Other Study ID Numbers	A9451157
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 2011

Locations[ + expand ][ + ]

Pfizer Investigational Site	Miami, Florida, United States, 33143
Pfizer Investigational Site	Atlanta, Georgia, United States, 30342
Pfizer Investigational Site	Overland Park, Kansas, United States, 66212
Pfizer Investigational Site	Cincinnati, Ohio, United States, 45227