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
1 other identifier
interventional
153
1 country
38
Brief Summary
To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2004
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 23, 2006
CompletedFirst Posted
Study publicly available on registry
August 24, 2006
CompletedFebruary 22, 2012
February 1, 2012
9 months
August 23, 2006
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean subjective wake time after sleep onset (WASO)
Week 1
Secondary Outcomes (22)
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
- +17 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALeszopiclone 3 mg
2
PLACEBO COMPARATORplacebo tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Santa Maria, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Danbury, Connecticut, United States
Unknown Facility
Hamden, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
Lansing, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Medford, New Jersey, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Mayfield Village, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Eugene, Oregon, United States
Unknown Facility
Bethlehem, Pennsylvania, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
West Reading, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Myrtle Beach, South Carolina, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Amarillo, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
Everett, Washington, United States
Related Publications (1)
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.
PMID: 20098520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2006
First Posted
August 24, 2006
Study Start
February 1, 2004
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
February 22, 2012
Record last verified: 2012-02