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A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666939
First Posted: April 25, 2008
Last Update Posted: April 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
April 23, 2008
April 25, 2008
April 25, 2008
October 2004
Not Provided
Subjective sleep latency [ Time Frame: Hour +8 ]
Same as current
No Changes Posted
  • Stanford Sleepiness Scale [ Time Frame: Hour +13 ]
  • Vital signs [ Time Frame: Hour +8 ]
  • Adverse events [ Time Frame: Hour +13 ]
  • Subjective number of awakenings [ Time Frame: Hour +8 ]
  • Subjective wake after sleep onset [ Time Frame: Hour +8 ]
  • Subjective total sleep time [ Time Frame: Hour +8 ]
  • Subjective assessment of sleep refreshment [ Time Frame: Hour +8 ]
  • Subjective assessment of sleep quality [ Time Frame: Hour +8 ]
  • Karolinska Sleep Diary-Sleep (KSD) Quality Index [ Time Frame: Hour +8 ]
  • KSD individual scores [ Time Frame: Hour +8 ]
  • Digit Symbol Substitution Test [ Time Frame: Hour +8 ]
  • Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) [ Time Frame: Hour +8 ]
Same as current
Not Provided
Not Provided
 
A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Transient Insomnia
  • 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
  • Experimental: A
    Intervention: Drug: Gabapentin
  • Experimental: B
    Intervention: Drug: Gabapentin
  • Placebo Comparator: C
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
773
January 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00666939
A9451141
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP