NCT00367965CompletedPhase 3
The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 153
- Primary Endpoint
- mean subjective wake time after sleep onset (WASO)
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
eszopiclone 3 mg
Intervention: Eszopiclone (Drug)
2
Placebo Comparator
placebo tablet
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
mean subjective wake time after sleep onset (WASO)
Time Frame: Week 1
Secondary Outcomes
- WASO(Weeks 2, 3, and 4)
- Number of nocturnal awakening(Weeks 1, 2, 3, and 4)
- Total sleep time (TST)(Weeks 1, 2, 3, and 4)
- Sleep Efficiency(Weeks 1, 2, 3, and 4)
- Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening(Weeks 1, 2, 3, and 4)
- Quality of sleep(Weeks 1, 2, 3, and 4)
- Depth of sleep(Weeks 1, 2, 3, and 4)
- Daytime alertness(Weeks 1, 2, 3, and 4)
- Ability to concentrate(Weeks 1, 2, 3, and 4)
- Physical well-being(Weeks 1, 2, 3, and 4)
- Ability to function(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(Weeks 1, 2, 3, and 4)
- Duration of morning stiffness(Weeks 1, 2, 3, and 4)
- Pain severity (from IVRS)(Weeks 1, 2, 3, and 4)
- Epworth Sleepiness Scale(Weeks 2 and 4)
- Insomnia Severity Index(Weeks 2 and 4)
- Arthritis Self-Efficacy Scale(Week 4)
- SF-36(Week 4)
- Physician Clinical Global Impression of treatment(Week 4)
- ACR Response Criteria(Week 4)
- Percentage of subjects with increase in dose or new prescription of pain medications(Weeks 1, 2, 3, 4)
- Percentage of subjects with increase in dose or new prescription of disease modifying medications(Weeks 1, 2, 3, 4)
Investigators
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