A Study of Single-Dose 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); 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 as compared to placebo on
sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a
sleep phase advance.
Clinical Details
Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter 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: Subjective sleep latency
Secondary outcome: Subjective assessment of sleep refreshmentSubjective assessment of sleep quality Karolinska Sleep Diary-Sleep (KSD) Quality Index KSD individual scores Digit Symbol Substitution Test Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) Stanford Sleepiness Scale Vital signs Adverse events Subjective number of awakenings Subjective wake after sleep onset Subjective total sleep time
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, San Diego, California 92121, United States
Pfizer Investigational Site, Anaheim, California 92801, United States
Pfizer Investigational Site, Orlando, Florida 32809, United States
Pfizer Investigational Site, Boise, Idaho 83704, United States
Pfizer Investigational Site, Mt. Laurel, New Jersey 08054, United States
Pfizer Investigational Site, Cincinnati, Ohio 45219, United States
Pfizer Investigational Site, Spartanburg, South Carolina 29307, United States
Pfizer Investigational Site, Dallas, Texas 75235, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date: October 2004
Ending date: January 2005
Last updated: April 23, 2008
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