- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00352144
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
21. februar 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
830
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater
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Huntsville, Alabama, Forente stater
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Arizona
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Phoenix, Arizona, Forente stater
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Scottsdale, Arizona, Forente stater
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California
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Anaheim, California, Forente stater
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Irvine, California, Forente stater
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Oakland, California, Forente stater
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Redlands, California, Forente stater
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San Diego, California, Forente stater
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Colorado
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Aurora, Colorado, Forente stater
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Denver, Colorado, Forente stater
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Longmont, Colorado, Forente stater
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Pueblo, Colorado, Forente stater
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Florida
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Clearwater, Florida, Forente stater
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Jacksonville, Florida, Forente stater
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Jupiter, Florida, Forente stater
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Naples, Florida, Forente stater
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Orlando, Florida, Forente stater
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Pembroke Pines, Florida, Forente stater
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Pinellas Park, Florida, Forente stater
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St. Petersburg, Florida, Forente stater
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Tampa, Florida, Forente stater
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Georgia
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Atlanta, Georgia, Forente stater
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Blairsville, Georgia, Forente stater
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Illinois
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Chicago, Illinois, Forente stater
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Elk Grove Village, Illinois, Forente stater
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Northbrook, Illinois, Forente stater
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Indiana
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Evansville, Indiana, Forente stater
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Kansas
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Olathe, Kansas, Forente stater
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Prairie Village, Kansas, Forente stater
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Maryland
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Chevy Chase, Maryland, Forente stater
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Frederick, Maryland, Forente stater
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Massachusetts
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Newton, Massachusetts, Forente stater
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Missouri
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Kansas City, Missouri, Forente stater
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St. Louis, Missouri, Forente stater
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Nebraska
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Lincoln, Nebraska, Forente stater
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Nevada
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Las Vegas, Nevada, Forente stater
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New Jersey
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Hamilton, New Jersey, Forente stater
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New York
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New York, New York, Forente stater
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North Carolina
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Cary, North Carolina, Forente stater
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Ohio
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Cincinatti, Ohio, Forente stater
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Cleveland, Ohio, Forente stater
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Columbus, Ohio, Forente stater
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Mogadore, Ohio, Forente stater
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater
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Oregon
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Eugene, Oregon, Forente stater
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Pennsylvania
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Bala Cynwyd, Pennsylvania, Forente stater
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South Carolina
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Anderson, South Carolina, Forente stater
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Columbia, South Carolina, Forente stater
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Texas
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Austin, Texas, Forente stater
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Dallas, Texas, Forente stater
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Houston, Texas, Forente stater
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Jackson, Texas, Forente stater
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Lubbock, Texas, Forente stater
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Plano, Texas, Forente stater
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San Antonio, Texas, Forente stater
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Wisconsin
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Brown Deer, Wisconsin, Forente stater
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Madison, Wisconsin, Forente stater
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: 2
Placebo tablett
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Placebo tablett
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Eksperimentell: 1
eszopiclone 3 mg tablet
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Eszopiklon 3 mg
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Average of Subjective Sleep Latency
Tidsramme: Days -14, 1, 30, 60, 90, 120, 150, 180
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Days -14, 1, 30, 60, 90, 120, 150, 180
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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
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Days -14, 1, 30, 60, 90, 120, 150, 180
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SF-36
Tidsramme: Days 1, 30, 90, 180
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Days 1, 30, 90, 180
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Work Limitations Questionnaire (WLQ)
Tidsramme: Days 1, 30, 90, 180
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Days 1, 30, 90, 180
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Insomnia Severity Index (ISI)
Tidsramme: Days 1, 30, 90, 180
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Days 1, 30, 90, 180
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Fatigue Severity Scale (FSS)
Tidsramme: Days 1, 30, 90, 180
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Days 1, 30, 90, 180
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Epworth Sleepiness Scale (ESS)
Tidsramme: Days 1, 30, 60, 90, 120, 150, 180
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Days 1, 30, 60, 90, 120, 150, 180
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Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)
Tidsramme: Day 180
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Day 180
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Healthcare Utilization Questionnaire (HUQ)
Tidsramme: Days 1, 30, 60, 90, 120, 150, 180
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Days 1, 30, 60, 90, 120, 150, 180
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2003
Primær fullføring (Faktiske)
1. oktober 2004
Studiet fullført (Faktiske)
1. oktober 2004
Datoer for studieregistrering
Først innsendt
12. juli 2006
Først innsendt som oppfylte QC-kriteriene
12. juli 2006
Først lagt ut (Anslag)
14. juli 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. februar 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. februar 2012
Sist bekreftet
1. februar 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 190-050
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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