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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00674752
First received: May 6, 2008
Last updated: April 22, 2011
Last verified: April 2011
History of Changes

May 6, 2008
April 22, 2011
March 2006
Not Provided
Wake after sleep onset as measured by polysomnography (PSG) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00674752 on ClinicalTrials.gov Archive Site
  • PSG Latency to Persistent Sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Wake Time During Sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG WASO [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Sleep Onset Latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Vital signs [ 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 ]
  • PSG NA [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Hour +13 ] [ Designated as safety issue: Yes ]
  • PSG Total wake time plus Stage 1 sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG TST [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Sleep Efficiency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Percent of Stages 1, 2, 3, 4 and REM sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Percent slow wave sleep (Stages 3&4 combined) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Sleep Latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Number of Awakenings (NA) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Wake After Sleep Onset (WASO) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Total Sleep Time (TST) [ 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 ]
Same as current
Not Provided
Not Provided
 
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
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

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in 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 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 oral capsule 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
377
August 2006
Not Provided

Inclusion Criteria:

  • Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
  • 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)
  • Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00674752
A9451157
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

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