To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia
9. august 2012 opdateret af: GlaxoSmithKline
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of SB-649868 (10, 30 mg and 60 mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia
This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
48
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Berlin, Tyskland, 10117
- GSK Investigational Site
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Berlin, Tyskland, 13125
- GSK Investigational Site
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Berlin, Tyskland, 10787
- GSK Investigational Site
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Hamburg, Tyskland, 20249
- GSK Investigational Site
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Baden-Wuerttemberg
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Mannheim, Baden-Wuerttemberg, Tyskland, 68159
- GSK Investigational Site
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Brandenburg
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Cottbus, Brandenburg, Tyskland, 03050
- GSK Investigational Site
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Mecklenburg-Vorpommern
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Schwerin, Mecklenburg-Vorpommern, Tyskland, 19055
- GSK Investigational Site
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Nordrhein-Westfalen
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Dortmund, Nordrhein-Westfalen, Tyskland, 44263
- GSK Investigational Site
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Muenster, Nordrhein-Westfalen, Tyskland, 48149
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01307
- GSK Investigational Site
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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
14 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Male
- 18-64 years of age (inclusive),
- Diagnosis of primary insomnia who have had symptoms for at least three months.
Exclusion Criteria:
- Any clinically significant unstable medical or surgical condition (treated or untreated).
- Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).
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: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Crossover population
All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing
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Active compound at doses of 10mg, 30mg and 60mg
Placebo to match SB-649868
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.
Tidsramme: 9 weeks
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Statistical paramaters of sleep measured by analysis of Polysomnography during night section of subject visit.
Measured for one night during each 4 study visits and twice at screening.
All visits will take in total approximately 9 weeks from screening to follow-up.
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9 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objective PSG measures of sleep continuity including: wake during sleep (WDS), wake after sleep (WAS), and number of awakenings during sleep. Objective PSG measures of sleep structure
Tidsramme: 9 weeks
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Real time Polysomnography technique using combination of EEG, ECG, EOG and EMG to collect data on physiological cleep activity.
Data/graphs are collected and analysed post sleep.
Measured for one night during each 4 study visits and twice at screening.
All visits will take in total approximately 9 weeks from screening to follow-up.
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9 weeks
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Objective PSG measures of sleep structure: Non-REM sleep time, Slow-Wave Sleep (SWS) time (stage 3 and 4), Stage 2 non-REM sleep time; REM sleep time, REM activity, REM density.
Tidsramme: 9 weeks
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Real time Polysomnography technique using combination of EEG, ECG, EOG and EMG to collect data on physiological cleep activity.
Data/graphs are collected and analysed post sleep.
Measured for one night during each 4 study visits and twice at screening.
All visits will take in total approximately 9 weeks from screening to follow-up.
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9 weeks
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Spectral analysis of EEG
Tidsramme: 9 weeks
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Collected as part of PSG.
Graph spectra can be quantitatively analysed to assess electrical activity in the brain.
Measured for one night during each 4 study visits and twice at screening.
All visits will take in total approximately 9 weeks from screening to follow-up.
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9 weeks
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Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording.
Tidsramme: 9 weeks
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Subject answers sleep quality questionnaires after night of sleep during the visit.
Measured for each morning after each 4 study night visits and twice at screening.
All visits will take in total approximately 9 weeks from screening to follow-up.
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9 weeks
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Daytime cognitive function data on the morning following dosing, including tests of alertness, memory, attention and fine motor control (i.e. Romberg, VAS for sleepiness/alertness, DSST, and immediate and delayed word recall).
Tidsramme: 9 weeks
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Measurements of insomnia effects on daytime regular functions
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9 weeks
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HVLT-R (verbal memory tests), TST, SOL, SQ, WAS and number of awakenings measured with the Post-Sleep Questionnaire score collected on specified mornings at home during the 3-day period following each 2-night PSG sessions.
Tidsramme: 9 weeks
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Further questionnaires answered after each visit regarding sleep quality.
Measured during night and day sections at each visit depending on the outcome.
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9 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. december 2006
Primær færdiggørelse (Faktiske)
1. maj 2007
Studieafslutning (Faktiske)
1. maj 2007
Datoer for studieregistrering
Først indsendt
23. januar 2007
Først indsendt, der opfyldte QC-kriterier
23. januar 2007
Først opslået (Skøn)
25. januar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. august 2012
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OXS107714
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