Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
NCT ID: NCT00367965
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
153 participants
INTERVENTIONAL
2004-02-29
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
eszopiclone 3 mg
Eszopiclone
eszopiclone 3 mg
2
placebo tablet
placebo
placebo tablet
Interventions
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Eszopiclone
eszopiclone 3 mg
placebo
placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
25 Years
64 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
Tucson, Arizona, United States
Santa Maria, California, United States
Whittier, California, United States
Danbury, Connecticut, United States
Hamden, Connecticut, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Fort Lauderdale, Florida, United States
Ocala, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Springfield, Illinois, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Fall River, Massachusetts, United States
Lansing, Michigan, United States
St Louis, Missouri, United States
Medford, New Jersey, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Mayfield Village, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Bethlehem, Pennsylvania, United States
Norristown, Pennsylvania, United States
West Reading, Pennsylvania, United States
Columbia, South Carolina, United States
Myrtle Beach, South Carolina, United States
Memphis, Tennessee, United States
Amarillo, Texas, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Everett, Washington, United States
Countries
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References
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Roth T, Price JM, Amato DA, Rubens RP, Roach JM, Schnitzer TJ. The effect of eszopiclone in patients with insomnia and coexisting rheumatoid arthritis: a pilot study. Prim Care Companion J Clin Psychiatry. 2009;11(6):292-301. doi: 10.4088/PCC.08m00749bro.
Other Identifiers
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190-055
Identifier Type: -
Identifier Source: org_study_id
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