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

Phase 3

Completed

• Conditions: Insomnia; Arthritis, Rheumatoid
• Interventions: Drug: placebo; Drug: Eszopiclone

• Registration Number: NCT00367965
• Lead Sponsor: Sumitomo Pharma America, Inc.

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 Timeline

• Study Start: 2004-02
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2006-08-23
• Study First Submitted QC: 2006-08-23
• Study First Posted: 2006-08-24
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo tablet
1	Eszopiclone	eszopiclone 3 mg

Primary Outcome Measures

Name	Time	Method
mean subjective wake time after sleep onset (WASO)	Week 1

Secondary Outcome Measures

Name	Time	Method
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