Status:
COMPLETED
Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Arthritis, Rheumatoid
Eligibility:
All Genders
25-64 years
Phase:
PHASE3
Brief Summary
To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).
Detailed Description
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 Sep...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00367965
Start Date
February 1 2004
End Date
November 1 2004
Last Update
February 22 2012
Active Locations (38)
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1
Huntsville, Alabama, United States
2
Tucson, Arizona, United States
3
Santa Maria, California, United States
4
Whittier, California, United States