A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
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 on polysomnographic
assessments in transient insomnia induced by a sleep phase advance.
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: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Wake after sleep onset as measured by polysomnography (PSG)
Secondary outcome: PSG Latency to Persistent SleepPSG Wake Time During Sleep PSG WASO PSG Sleep Onset Latency Vital signs Karolinska Sleep Diary-Sleep (KSD) Quality Index KSD individual scores PSG NA Adverse events PSG Total wake time plus Stage 1 sleep PSG TST PSG Sleep Efficiency PSG Percent of Stages 1, 2, 3, 4 and REM sleep PSG Percent slow wave sleep (Stages 3&4 combined) subjective Sleep Latency subjective Number of Awakenings (NA) subjective Wake After Sleep Onset (WASO) subjective Total Sleep Time (TST) subjective Assessment of Sleep Refreshment subjective Assessment of Sleep Quality
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, Miami, Florida 33143, United States
Pfizer Investigational Site, Atlanta, Georgia 30342, United States
Pfizer Investigational Site, Overland Park, Kansas 66212, United States
Pfizer Investigational Site, Cincinnati, Ohio 45227, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date: March 2006
Ending date: August 2006
Last updated: May 8, 2008
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