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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00666939
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 23, 2008
April 23, 2008
October 2004
Not Provided
Subjective sleep latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Stanford Sleepiness Scale [ Time Frame: Hour +13 ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Hour +8 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Hour +13 ] [ Designated as safety issue: Yes ]
  • Subjective number of awakenings [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Subjective wake after sleep onset [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Subjective total sleep time [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Subjective assessment of sleep refreshment [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Subjective assessment of sleep quality [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Karolinska Sleep Diary-Sleep (KSD) Quality Index [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • KSD individual scores [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Test [ Time Frame: Hour +8 ] [ Designated as 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00666939
A9451141
No
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