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

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00367965

Collaborator

(none)

153

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).

Condition or Disease	Intervention/Treatment	Phase
Insomnia Arthritis, Rheumatoid	Drug: Eszopiclone Drug: placebo	Phase 3

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

Actual Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Nov 1, 2004

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 eszopiclone 3 mg	Drug: Eszopiclone eszopiclone 3 mg Other Names: Lunesta S-zopiclone
Placebo Comparator: 2 placebo tablet	Drug: placebo placebo tablet

Arm

Intervention/Treatment

Experimental: 1

eszopiclone 3 mg

Drug: Eszopiclone

eszopiclone 3 mg

Other Names:

Lunesta

S-zopiclone

Placebo Comparator: 2

placebo tablet

Drug: placebo

placebo tablet

Outcome Measures

Primary Outcome Measures

mean subjective wake time after sleep onset (WASO) [Week 1]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	Huntsville	Alabama	United States
2	Tucson	Arizona	United States
3	Santa Maria	California	United States
4	Whittier	California	United States
5	Danbury	Connecticut	United States
6	Hamden	Connecticut	United States
7	Washington	District of Columbia	United States
8	Aventura	Florida	United States
9	Clearwater	Florida	United States
10	Ft. Lauderdale	Florida	United States
11	Ocala	Florida	United States
12	Sarasota	Florida	United States
13	Tampa	Florida	United States
14	Vero Beach	Florida	United States
15	Springfield	Illinois	United States
16	Kansas City	Kansas	United States
17	Overland Park	Kansas	United States
18	Louisville	Kentucky	United States
19	Fall River	Massachusetts	United States
20	Lansing	Michigan	United States
21	St. Louis	Missouri	United States
22	Medford	New Jersey	United States
23	Rochester	New York	United States
24	Winston-Salem	North Carolina	United States
25	Fargo	North Dakota	United States
26	Mayfield Village	Ohio	United States
27	Oklahoma City	Oklahoma	United States
28	Eugene	Oregon	United States
29	Bethlehem	Pennsylvania	United States
30	Norristown	Pennsylvania	United States
31	West Reading	Pennsylvania	United States
32	Columbia	South Carolina	United States
33	Myrtle Beach	South Carolina	United States
34	Memphis	Tennessee	United States
35	Amarillo	Texas	United States
36	Dallas	Texas	United States
37	Lubbock	Texas	United States
38	Everett	Washington	United States