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

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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Insomnia
• Intervention / Treatment: Drug: Eszopiclone; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Santa Maria, California, United States
    • Whittier, California, United States
  • Connecticut
    • Danbury, Connecticut, United States
    • Hamden, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Aventura, Florida, United States
    • Clearwater, Florida, United States
    • Ft. Lauderdale, Florida, United States
    • Ocala, Florida, United States
    • Sarasota, Florida, United States
    • Tampa, Florida, United States
    • Vero Beach, Florida, United States
  • Illinois
    • Springfield, Illinois, United States
  • Kansas
    • Kansas City, Kansas, United States
    • Overland Park, Kansas, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • Massachusetts
    • Fall River, Massachusetts, United States
  • Michigan
    • Lansing, Michigan, United States
  • Missouri
    • St. Louis, Missouri, United States
  • New Jersey
    • Medford, New Jersey, United States
  • New York
    • Rochester, New York, United States
  • North Carolina
    • Winston-Salem, North Carolina, United States
  • North Dakota
    • Fargo, North Dakota, United States
  • Ohio
    • Mayfield Village, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Eugene, Oregon, United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States
    • Norristown, Pennsylvania, United States
    • West Reading, Pennsylvania, United States
  • South Carolina
    • Columbia, South Carolina, United States
    • Myrtle Beach, South Carolina, United States
  • Tennessee
    • Memphis, Tennessee, United States
  • Texas
    • Amarillo, Texas, United States
    • Dallas, Texas, United States
    • Lubbock, Texas, United States
  • Washington
    • Everett, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean subjective wake time after sleep onset (WASO)	Week 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sunovion

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: August 23, 2006
• First Submitted That Met QC Criteria: August 23, 2006
• First Posted (Estimate): August 24, 2006

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Insomnia related to rheumatoid arthritis (RA)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone; Zopiclone
• Other Study ID Numbers: 190-055