A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
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); 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 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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Secondary outcome: PSG WAPSOPSG Latency to Persistent Sleep (LPS) PSG Sleep Onset Latency (SOL) PSG Number of Awakenings (NAW) PSG Wake after Sleep Onset (WASO) PSG Total Wake Time (TWT) plus Stage 1 Sleep PSG Wake Time During Sleep (WTDS) PSG Total Sleep Time (TST) PSG Sleep Efficiency (SE) PSG Percent of Stages 1, 2, 3, 4 and REM sleep PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined) Subjective SL Subjective NA Subjective WASO Subjective TST Subjective ASR Subjective ASQ Karolinska Sleep Diary (KSD)-Sleep Quality Index KSD individual scores Vital signs Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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 66212, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date: October 2005
Ending date: April 2006
Last updated: April 23, 2008
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