A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance | RxWiki

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
Condition	Transient Insomnia
Intervention	Drug: Gabapentin Drug: Placebo
Phase	Phase 3
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00163046
First Received	September 8, 2005
Last Updated	April 23, 2008
Last verified	April 2008

Tracking Information[ + expand ][ + ]

First Received Date	September 8, 2005
Last Updated Date	April 23, 2008
Start Date	October 2005
Estimated Primary Completion Date	April 2006
Current Primary Outcome Measures	Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO) [Time Frame: Day 1] [Designated as safety issue: No]
Current Secondary Outcome Measures	PSG WAPSO [Time Frame: Day 28] [Designated as safety issue: No] PSG Latency to Persistent Sleep (LPS) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Sleep Onset Latency (SOL) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Number of Awakenings (NAW) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Wake after Sleep Onset (WASO) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Total Wake Time (TWT) plus Stage 1 Sleep [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Wake Time During Sleep (WTDS) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Total Sleep Time (TST) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Sleep Efficiency (SE) [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Percent of Stages 1, 2, 3, 4 and REM sleep [Time Frame: Days 1 and 28] [Designated as safety issue: No] PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined) [Time Frame: Days 1 and 28] [Designated as safety issue: No] Subjective SL [Time Frame: Days 1 and 28] [Designated as safety issue: No] Subjective NA [Time Frame: Days 1 and 28] [Designated as safety issue: No] Subjective WASO [Time Frame: Days 1 and 28] [Designated as safety issue: No] Subjective TST [Time Frame: Days 1 and 28] [Designated as safety issue: No] Subjective ASR [Time Frame: Days 1 and 28] [Designated as safety issue: No] Subjective ASQ [Time Frame: Days 1 and 28] [Designated as safety issue: No] Karolinska Sleep Diary (KSD)-Sleep Quality Index [Time Frame: Days 1 and 28] [Designated as safety issue: No] KSD individual scores [Time Frame: Days 1 and 28] [Designated as safety issue: No] Vital signs [Time Frame: Days 1 and 28] [Designated as safety issue: Yes] Adverse events [Time Frame: Through Day 32] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official Title	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-Day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance
Brief Summary	The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with 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 for 28 days Drug: Placebo Matched placebo 30 minutes prior to bedtime for 28 days
Study Arm (s)	Experimental: Gabapentin Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	256
Estimated Completion Date	April 2006
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: - 18 years of age or older with occasional sleeplessness in the month prior to screening Exclusion Criteria: - Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep - Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00163046
Other Study ID Numbers	A9451155
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, 66212