Clinical trial NCT00367965: Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Official title: The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Arthritis, Rheumatoid
Keywords: Insomnia related to rheumatoid arthritis (RA)
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 153
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean subjective wake time after sleep onset (WASO)
timeFrame: Week 1
Secondary outcomes:
measure: WASO
timeFrame: Weeks 2, 3, and 4
measure: Number of nocturnal awakening
timeFrame: Weeks 1, 2, 3, and 4
measure: Total sleep time (TST)
timeFrame: Weeks 1, 2, 3, and 4
measure: Sleep Efficiency
timeFrame: Weeks 1, 2, 3, and 4
measure: Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening
timeFrame: Weeks 1, 2, 3, and 4
measure: Quality of sleep
timeFrame: Weeks 1, 2, 3, and 4
measure: Depth of sleep
timeFrame: Weeks 1, 2, 3, and 4
measure: Daytime alertness
timeFrame: Weeks 1, 2, 3, and 4
measure: Ability to concentrate
timeFrame: Weeks 1, 2, 3, and 4
measure: Physical well-being
timeFrame: Weeks 1, 2, 3, and 4
measure: Ability to function
timeFrame: Weeks 1, 2, 3, and 4
measure: 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
timeFrame: Weeks 1, 2, 3, and 4
measure: Duration of morning stiffness
timeFrame: Weeks 1, 2, 3, and 4
measure: Pain severity (from IVRS)
timeFrame: Weeks 1, 2, 3, and 4
measure: Epworth Sleepiness Scale
timeFrame: Weeks 2 and 4
measure: Insomnia Severity Index
timeFrame: Weeks 2 and 4
measure: Arthritis Self-Efficacy Scale
timeFrame: Week 4
measure: SF-36
timeFrame: Week 4
measure: Physician Clinical Global Impression of treatment
timeFrame: Week 4
measure: ACR Response Criteria
timeFrame: Week 4
measure: Percentage of subjects with increase in dose or new prescription of pain medications
timeFrame: Weeks 1, 2, 3, 4
measure: Percentage of subjects with increase in dose or new prescription of disease modifying medications
timeFrame: Weeks 1, 2, 3, 4
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Santa Maria
country: United States
state: California
city: Whittier
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Hamden
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Fall River
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Medford
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Mayfield Village
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Everett
country: United States
state: Washington
Study officials:
References:
citation: Roth T, Price JM, Amato DA, Rubens RP, Roach JM, Schnitzer TJ. The effect of eszopiclone in patients with insomnia and coexisting rheumatoid arthritis: a pilot study. Prim Care Companion J Clin Psychiatry. 2009;11(6):292-301. doi: 10.4088/PCC.08m00749bro.