To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
153
eszopiclone 3 mg
placebo tablet
mean subjective wake time after sleep onset (WASO)
Time frame: Week 1
WASO
Time frame: Weeks 2, 3, and 4
Number of nocturnal awakening
Time frame: Weeks 1, 2, 3, and 4
Total sleep time (TST)
Time frame: Weeks 1, 2, 3, and 4
Sleep Efficiency
Time frame: Weeks 1, 2, 3, and 4
Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening
Time frame: Weeks 1, 2, 3, and 4
Quality of sleep
Time frame: Weeks 1, 2, 3, and 4
Depth of sleep
Time frame: Weeks 1, 2, 3, and 4
Daytime alertness
Time frame: Weeks 1, 2, 3, and 4
Ability to concentrate
Time frame: Weeks 1, 2, 3, and 4
Physical well-being
Time frame: Weeks 1, 2, 3, and 4
Ability to function
Time frame: 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
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Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Santa Maria, California, United States
Unnamed facility
Whittier, California, United States
Unnamed facility
Danbury, Connecticut, United States
Unnamed facility
Hamden, Connecticut, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Aventura, Florida, United States
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Fort Lauderdale, Florida, United States
...and 28 more locations
Time frame: Weeks 1, 2, 3, and 4
Duration of morning stiffness
Time frame: Weeks 1, 2, 3, and 4
Pain severity (from IVRS)
Time frame: Weeks 1, 2, 3, and 4
Epworth Sleepiness Scale
Time frame: Weeks 2 and 4
Insomnia Severity Index
Time frame: Weeks 2 and 4
Arthritis Self-Efficacy Scale
Time frame: Week 4
SF-36
Time frame: Week 4
Physician Clinical Global Impression of treatment
Time frame: Week 4
ACR Response Criteria
Time frame: Week 4
Percentage of subjects with increase in dose or new prescription of pain medications
Time frame: Weeks 1, 2, 3, 4
Percentage of subjects with increase in dose or new prescription of disease modifying medications
Time frame: Weeks 1, 2, 3, 4