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6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

21. februar 2012 opdateret af: Sunovion

A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study

To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

830

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
      • Huntsville, Alabama, Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater
      • Scottsdale, Arizona, Forenede Stater
    • California
      • Anaheim, California, Forenede Stater
      • Irvine, California, Forenede Stater
      • Oakland, California, Forenede Stater
      • Redlands, California, Forenede Stater
      • San Diego, California, Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater
      • Denver, Colorado, Forenede Stater
      • Longmont, Colorado, Forenede Stater
      • Pueblo, Colorado, Forenede Stater
    • Florida
      • Clearwater, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Jupiter, Florida, Forenede Stater
      • Naples, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
      • Pembroke Pines, Florida, Forenede Stater
      • Pinellas Park, Florida, Forenede Stater
      • St. Petersburg, Florida, Forenede Stater
      • Tampa, Florida, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
      • Blairsville, Georgia, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
      • Elk Grove Village, Illinois, Forenede Stater
      • Northbrook, Illinois, Forenede Stater
    • Indiana
      • Evansville, Indiana, Forenede Stater
    • Kansas
      • Olathe, Kansas, Forenede Stater
      • Prairie Village, Kansas, Forenede Stater
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater
      • Frederick, Maryland, Forenede Stater
    • Massachusetts
      • Newton, Massachusetts, Forenede Stater
    • Missouri
      • Kansas City, Missouri, Forenede Stater
      • St. Louis, Missouri, Forenede Stater
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
    • New Jersey
      • Hamilton, New Jersey, Forenede Stater
    • New York
      • New York, New York, Forenede Stater
    • North Carolina
      • Cary, North Carolina, Forenede Stater
    • Ohio
      • Cincinatti, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
      • Columbus, Ohio, Forenede Stater
      • Mogadore, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Oregon
      • Eugene, Oregon, Forenede Stater
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, Forenede Stater
    • South Carolina
      • Anderson, South Carolina, Forenede Stater
      • Columbia, South Carolina, Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
      • Jackson, Texas, Forenede Stater
      • Lubbock, Texas, Forenede Stater
      • Plano, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
    • Wisconsin
      • Brown Deer, Wisconsin, Forenede Stater
      • Madison, Wisconsin, Forenede Stater

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

21 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • Subject meets DSM-IV criteria for primary insomnia and reports sleeping no more than 6.5 hours per night and/or taking more than 30 minutes each night to fall asleep for at least one month prior to screening.
  • Male and female subjects must be between 21 and 64 years of age, inclusive, at the time of consent.
  • Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form. Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
  • Subject must be in general good health, based on screening physical examination (including brief neurological examination), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

Exclusion Criteria

  • Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
  • Subject has a history of cancer within the past 5 years, or current malignancy except for non melanomatous skin cancer.
  • Subject has a psychiatric diagnosis with psychosis, dementia or delirium. Subjects with Sexual and Gender Identity Disorders or other non-psychotic disorders will be considered on a case-by-case basis.
  • Subject has one of the following Personality Disorders: schizotypal, schizoid, or borderline personality disorder.
  • Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis (e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that has or may affect sleep (e.g., chronic pain, BPH, etc.).
  • Subject has participated in a previous eszopiclone clinical trial.
  • Subject has a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative hypnotic, any substance that is contained in the formulation, or has been hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug hypersensitivity, drug allergy, etc.).
  • Subject has history of substance abuse in the past 10 years or substance dependence at any time or positive urine drug test at screening .
  • Subject tests positive at screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
  • Subject is known to be seropositive for HIV.
  • Female subjects who are pregnant, lactating or within 6 months post partum.
  • Subject self-reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
  • Subject has taken any psychotropic medications or other medications known to affect sleep within the 3 days prior to screening visit or is anticipated to need any of these types of medications during double-blind treatment .
  • Subject has participated in any investigational study within 30 days prior to screening.
  • Subject has taken herbal supplements, purported to have central nervous system effects,(tablets, powders, extracts or tinctures) or combination products with herbs or melatonin within 14 days prior to screening or St. John's Wort within 30 days prior to screening.
  • Subject is a rotating or third/night shift worker.
  • Subject is a staff member or relative of a staff member.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 2
Placebo tablet
Medicin: Placebo
Placebo tablet
Eksperimentel: 1
eszopiclone 3 mg tablet
Medicin: Eszopiclon
Eszopiclon 3 mg
Andre navne:
  • Lunesta
  • S-zopiklon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Average of Subjective Sleep Latency
Tidsramme: Days -14, 1, 30, 60, 90, 120, 150, 180
Days -14, 1, 30, 60, 90, 120, 150, 180

Sekundære resultatmål

Resultatmål
Tidsramme
Average of Total Sleep Time (TST) and Wake Time After Sleep Onset (WASO)
Tidsramme: Days -14, 1, 30, 60, 90, 120, 150, 180
Days -14, 1, 30, 60, 90, 120, 150, 180
SF-36
Tidsramme: Days 1, 30, 90, 180
Days 1, 30, 90, 180
Work Limitations Questionnaire (WLQ)
Tidsramme: Days 1, 30, 90, 180
Days 1, 30, 90, 180
Insomnia Severity Index (ISI)
Tidsramme: Days 1, 30, 90, 180
Days 1, 30, 90, 180
Fatigue Severity Scale (FSS)
Tidsramme: Days 1, 30, 90, 180
Days 1, 30, 90, 180
Epworth Sleepiness Scale (ESS)
Tidsramme: Days 1, 30, 60, 90, 120, 150, 180
Days 1, 30, 60, 90, 120, 150, 180
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)
Tidsramme: Day 180
Day 180
Healthcare Utilization Questionnaire (HUQ)
Tidsramme: Days 1, 30, 60, 90, 120, 150, 180
Days 1, 30, 60, 90, 120, 150, 180

Samarbejdspartnere og efterforskere

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

Sponsor

Sunovion

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. oktober 2003

Primær færdiggørelse (Faktiske)

1. oktober 2004

Studieafslutning (Faktiske)

1. oktober 2004

Datoer for studieregistrering

Først indsendt

12. juli 2006

Først indsendt, der opfyldte QC-kriterier

12. juli 2006

Først opslået (Skøn)

14. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 190-050

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 .

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