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

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ClinicalTrials.gov Identifier: NCT00666770
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : April 25, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 23, 2008
First Posted Date  ICMJE April 25, 2008
Last Update Posted Date April 25, 2008
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)		 Latency to persistent sleep as measured by polysomnography [ Time Frame: Hour +8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
  • 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 ]
  • Stanford Sleepiness Scale [ Time Frame: Hour +13 ]
  • 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 ]
  • Latency to REM sleep [ Time Frame: Hour +8 ]
  • Number of awakenings [ Time Frame: Hour +8 ]
  • Wake after sleep onset [ Time Frame: Hour +8 ]
  • Total wake time plus Stage 1 sleep [ Time Frame: Hour +8 ]
  • Total sleep time [ Time Frame: Hour +8 ]
  • Sleep efficiency [ Time Frame: Hour +8 ]
  • Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep [ 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 ]
  • Vital signs [ Time Frame: Hour +8 ]
  • Adverse events [ Time Frame: Hour +13 ]
  • Sleep onset latency [ Time Frame: Hour +8 ]
  • Percent slow wave sleep (Stages 3&4 combined) [ Time Frame: Hour +8 ]
  • Subjective sleep latency [ Time Frame: Hour +8 ]
  • Subjective number of awakenings [ Time Frame: Hour +8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official Title  ICMJE A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance
Brief Summary The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Transient Insomnia
Intervention  ICMJE
  • Drug: Gabapentin
    Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
  • Drug: Gabapentin
    Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
  • Drug: Placebo
    Matched placebo 30 minutes prior to bedtime
Study Arms  ICMJE
  • Experimental: Gabapentin 250 mg
    Intervention: Drug: Gabapentin
  • Experimental: Gabapentin 500 mg
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2008)		 309
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666770
Other Study ID Numbers  ICMJE A9451139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

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