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Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis

21. februar 2012 opdateret af: Sunovion

The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis

To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A multicenter, randomized, double-blind, placebo controlled, parallel group study of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis. 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)

153

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
      • Huntsville, Alabama, Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater
    • California
      • Santa Maria, California, Forenede Stater
      • Whittier, California, Forenede Stater
    • Connecticut
      • Danbury, Connecticut, Forenede Stater
      • Hamden, Connecticut, Forenede Stater
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater
    • Florida
      • Aventura, Florida, Forenede Stater
      • Clearwater, Florida, Forenede Stater
      • Ft. Lauderdale, Florida, Forenede Stater
      • Ocala, Florida, Forenede Stater
      • Sarasota, Florida, Forenede Stater
      • Tampa, Florida, Forenede Stater
      • Vero Beach, Florida, Forenede Stater
    • Illinois
      • Springfield, Illinois, Forenede Stater
    • Kansas
      • Kansas City, Kansas, Forenede Stater
      • Overland Park, Kansas, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
    • Massachusetts
      • Fall River, Massachusetts, Forenede Stater
    • Michigan
      • Lansing, Michigan, Forenede Stater
    • Missouri
      • St. Louis, Missouri, Forenede Stater
    • New Jersey
      • Medford, New Jersey, Forenede Stater
    • New York
      • Rochester, New York, Forenede Stater
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater
    • North Dakota
      • Fargo, North Dakota, Forenede Stater
    • Ohio
      • Mayfield Village, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Oregon
      • Eugene, Oregon, Forenede Stater
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater
      • Norristown, Pennsylvania, Forenede Stater
      • West Reading, Pennsylvania, Forenede Stater
    • South Carolina
      • Columbia, South Carolina, Forenede Stater
      • Myrtle Beach, South Carolina, Forenede Stater
    • Tennessee
      • Memphis, Tennessee, Forenede Stater
    • Texas
      • Amarillo, Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Lubbock, Texas, Forenede Stater
    • Washington
      • Everett, Washington, 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

25 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
  • Subject must be 25-64 years of age (inclusive) on the day of signing consent.
  • Subject must be diagnosed with rheumatoid arthritis as defined by the American College of Rheumatology.
  • Subject must be on stable regimen for treatment of rheumatoid arthritis for a minimum of 90 days prior to study start.
  • Subject must report a wake time after sleep onset (WASO) of greater than or equal to 45 minutes and less than or equal to 6.5 hours of total sleep time at least three times a week over the previous month and symptoms of insomnia must post date onset of rheumatoid arthritis.
  • Subject physical exam must show no clinically significant abnormal findings (other than those related to rheumatoid arthritis) at screening.
  • Subject must have no clinically significant abnormal laboratory findings at screening (other than those related to rheumatoid arthritis).
  • Subject must have no clinically significant ECG abnormalities at screening.

Exclusion Criteria

  • Subject has diagnosis of fibromyalgia, or juvenile rheumatoid arthritis.
  • Subject has history of circadian rhythm disorder, or travels across >3 time zones on a regular basis.
  • Female subject is pregnant, lactating or within 6-months post partum.
  • Subject has a history of drug or alcohol abuse or dependence in the past 2 years or positive urine drug test at screening.
  • Subject has clinically significant unstable medical abnormality or unstable chronic disease (other than insomnia and rheumatoid arthritis) including severe cardiac, renal, or hepatic or respiratory disease, seizure disorder.
  • Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in any investigational drug study during participation in this study.
  • Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
  • Subject has a current primary psychiatric diagnosis of any of the following disorders: dementia, delirium, schizophrenia, psychosis, other psychotic disorders, dysthymic disorder; major depressive disorder, bipolar disorders; cyclothymic disorder, other mood disorders, primary anxiety disorders, primary panic disorders, or any nocturnal panic disorder.
  • Subject has any of the following Personality Disorders diagnoses: schizotypal, schizoid, borderline personality disorder; or any other personality disorder that would compromise the investigator's ability to evaluate the safety and efficacy of the study medication.
  • Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis [e.g. sleep apnea]; diagnosed and untreated restless leg syndrome (RLS) or periodic leg movement syndrome (PLMS).
  • Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
  • Subject 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 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
Eksperimentel: 1
eszopiclon 3 mg
Medicin: Eszopiclon
eszopiclon 3 mg
Andre navne:
  • Lunesta
  • S-zopiclon
Placebo komparator: 2
placebo tablet
Medicin: placebo
placebotablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
mean subjective wake time after sleep onset (WASO)
Tidsramme: Week 1
Week 1

Sekundære resultatmål

Resultatmål
Tidsramme
Årvågenhed i dagtimerne
Tidsramme: Uge 1, 2, 3 og 4
Uge 1, 2, 3 og 4
Evne til at koncentrere sig
Tidsramme: Uge 1, 2, 3 og 4
Uge 1, 2, 3 og 4
Fysisk velvære
Tidsramme: Uge 1, 2, 3 og 4
Uge 1, 2, 3 og 4
Evne til at fungere
Tidsramme: Uge 1, 2, 3 og 4
Uge 1, 2, 3 og 4
WASO
Tidsramme: Weeks 2, 3, and 4
Weeks 2, 3, and 4
Number of nocturnal awakening
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Total sleep time (TST)
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Sleep Efficiency
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Quality of sleep
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Depth of sleep
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
occurrence of rebound insomnia and withdrawal effects will be assessed for WASO, and TST as well as for SL in subjects with sleep latency of 30 minutes or greater at screening
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Duration of morning stiffness
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Pain severity (from IVRS)
Tidsramme: Weeks 1, 2, 3, and 4
Weeks 1, 2, 3, and 4
Epworth Sleepiness Scale
Tidsramme: Weeks 2 and 4
Weeks 2 and 4
Insomnia Severity Index
Tidsramme: Weeks 2 and 4
Weeks 2 and 4
Arthritis Self-Efficacy Scale
Tidsramme: Week 4
Week 4
SF-36
Tidsramme: Week 4
Week 4
Physician Clinical Global Impression of treatment
Tidsramme: Week 4
Week 4
ACR Response Criteria
Tidsramme: Week 4
Week 4
Percentage of subjects with increase in dose or new prescription of pain medications
Tidsramme: Weeks 1, 2, 3, 4
Weeks 1, 2, 3, 4
Percentage of subjects with increase in dose or new prescription of disease modifying medications
Tidsramme: Weeks 1, 2, 3, 4
Weeks 1, 2, 3, 4

Samarbejdspartnere og efterforskere

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

Sponsor

Sunovion

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. februar 2004

Primær færdiggørelse (Faktiske)

1. november 2004

Studieafslutning (Faktiske)

1. november 2004

Datoer for studieregistrering

Først indsendt

23. august 2006

Først indsendt, der opfyldte QC-kriterier

23. august 2006

Først opslået (Skøn)

24. august 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

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 190-055

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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