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Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

14. april 2015 opdateret af: GlaxoSmithKline

A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.

This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

342

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2X 2A8
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5B4M4
        • GSK Investigational Site
      • Niagara Falls, Ontario, Canada, L2G 1J4
        • GSK Investigational Site
      • Parrry Sound, Ontario, Canada, P2A 1T3
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1E2
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4P 1P2
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5T3A9
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M6J 3S3
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35213
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85050
        • GSK Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • GSK Investigational Site
    • California
      • Burbank, California, Forenede Stater, 91506
        • GSK Investigational Site
      • Huntington Beach, California, Forenede Stater, 92648
        • GSK Investigational Site
      • Irvine, California, Forenede Stater, 92618
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90048
        • GSK Investigational Site
      • National City, California, Forenede Stater, 91950
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92123
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92161
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92121
        • GSK Investigational Site
      • San Francisco, California, Forenede Stater, 94105
        • GSK Investigational Site
      • Santa Rosa, California, Forenede Stater, 95405
        • GSK Investigational Site
    • Connecticut
      • Norwalk, Connecticut, Forenede Stater, 06850
        • GSK Investigational Site
    • Florida
      • Deland, Florida, Forenede Stater, 32720
        • GSK Investigational Site
      • Delray Beach, Florida, Forenede Stater, 33484
        • GSK Investigational Site
      • Hallandale Beach, Florida, Forenede Stater, 33009
        • GSK Investigational Site
      • Largo, Florida, Forenede Stater, 33773
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33143
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33173
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33176
        • GSK Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33026
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30328
        • GSK Investigational Site
      • Gainesville, Georgia, Forenede Stater, 30501
        • GSK Investigational Site
      • Hinesville, Georgia, Forenede Stater, 31313
        • GSK Investigational Site
      • Macon, Georgia, Forenede Stater, 31201
        • GSK Investigational Site
      • Stockbridge, Georgia, Forenede Stater, 30281
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • GSK Investigational Site
      • Chicago, Illinois, Forenede Stater, 60612
        • GSK Investigational Site
      • Chicago, Illinois, Forenede Stater, 60634
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66211
        • GSK Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, Forenede Stater, 41017
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • GSK Investigational Site
    • Massachusetts
      • Newton, Massachusetts, Forenede Stater, 02459
        • GSK Investigational Site
    • Michigan
      • Troy, Michigan, Forenede Stater, 48085
        • GSK Investigational Site
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39404
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89104
        • GSK Investigational Site
    • New Jersey
      • Clementon, New Jersey, Forenede Stater, 08021
        • GSK Investigational Site
    • New York
      • West Seneca, New York, Forenede Stater, 14224
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • GSK Investigational Site
      • Salisbury, North Carolina, Forenede Stater, 28144
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • GSK Investigational Site
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • GSK Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45246
        • GSK Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45227
        • GSK Investigational Site
      • Cleveland, Ohio, Forenede Stater, 44130
        • GSK Investigational Site
      • Gallipolis, Ohio, Forenede Stater, 45631
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • GSK Investigational Site
    • Oregon
      • Gresham, Oregon, Forenede Stater, 97020
        • GSK Investigational Site
    • Pennsylvania
      • Clarks Summit, Pennsylvania, Forenede Stater, 18411
        • GSK Investigational Site
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29201
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78756
        • GSK Investigational Site
      • Bellaire, Texas, Forenede Stater, 77401
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75251
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • GSK Investigational Site
      • Plano, Texas, Forenede Stater, 75093
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Difficulty going to sleep and/or staying asleep for at least the past 3 months.
  • Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
  • Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria:

  • History of other sleep disorders such as sleep apnea or restless leg syndrome.
  • Regular sleep habits, including bedtime between 9 PM and midnight.
  • No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
  • Use of nicotine, caffeine and alcoholic products.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.
Tidsramme: 28 Days
28 Days

Sekundære resultatmål

Resultatmål
Tidsramme
Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.
Tidsramme: 28 Days
28 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)

1. februar 2007

Datoer for studieregistrering

Først indsendt

19. januar 2006

Først indsendt, der opfyldte QC-kriterier

19. januar 2006

Først opslået (Skøn)

23. januar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MAD103894

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner