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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00367965
First received: August 23, 2006
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Insomnia
Arthritis, Rheumatoid
Drug: Eszopiclone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • mean subjective wake time after sleep onset (WASO) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WASO [ Time Frame: Weeks 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Number of nocturnal awakening [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Total sleep time (TST) [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Sleep Efficiency [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Quality of sleep [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Depth of sleep [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Daytime alertness [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Ability to concentrate [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Physical well-being [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Ability to function [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Duration of morning stiffness [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Pain severity (from IVRS) [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
  • Arthritis Self-Efficacy Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Physician Clinical Global Impression of treatment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • ACR Response Criteria [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects with increase in dose or new prescription of pain medications [ Time Frame: Weeks 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects with increase in dose or new prescription of disease modifying medications [ Time Frame: Weeks 1, 2, 3, 4 ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: February 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
eszopiclone 3 mg
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
  • Lunesta
  • S-zopiclone
Placebo Comparator: 2
placebo tablet
Drug: placebo
placebo tablet

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

Ages Eligible for Study:   25 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367965

  Show 38 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00367965     History of Changes
Other Study ID Numbers: 190-055
Study First Received: August 23, 2006
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Insomnia related to rheumatoid arthritis (RA)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Sleep Initiation and Maintenance Disorders
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014