Official Title: “A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • Gabapentin 100 mg oral capsule 30 minutes prior to bedtime
• Drug: Gabapentin
  • Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
• Drug: Placebo
  • Matched placebo 30 minutes prior to bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Placebo Comparator: C

Primary Measures

• Subjective sleep latency
  • Time Frame: Hour +8
    Safety Issue?: No

Secondary Measures

• Stanford Sleepiness Scale
  • Time Frame: Hour +13
    Safety Issue?: No
• Vital signs
  • Time Frame: Hour +8
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Hour +13
    Safety Issue?: Yes
• Subjective number of awakenings
  • Time Frame: Hour +8
    Safety Issue?: No
• Subjective wake after sleep onset
  • Time Frame: Hour +8
    Safety Issue?: No
• Subjective total sleep time
  • Time Frame: Hour +8
    Safety Issue?: No
• Subjective assessment of sleep refreshment
  • Time Frame: Hour +8
    Safety Issue?: No
• Subjective assessment of sleep quality
  • Time Frame: Hour +8
    Safety Issue?: No
• Karolinska Sleep Diary-Sleep (KSD) Quality Index
  • Time Frame: Hour +8
    Safety Issue?: No
• KSD individual scores
  • Time Frame: Hour +8
    Safety Issue?: No
• Digit Symbol Substitution Test
  • Time Frame: Hour +8
    Safety Issue?: No
• Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
  • Time Frame: Hour +8
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666939

Study ID Number: A9451141

ClinicalTrials.gov Identifier: NCT00666939

Health Authority: United States: Food and Drug Administration

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