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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367965
• Other study ID #: 190-055
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2006
• Last updated: February 21, 2012
• Start date: February 2004
• Est. completion date: November 2004

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Insomnia

Intervention

Drug:
• Eszopiclone
eszopiclone 3 mg
• placebo
placebo tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean subjective wake time after sleep onset (WASO)		Week 1	No
Secondary	WASO		Weeks 2, 3, and 4	No
Secondary	Number of nocturnal awakening		Weeks 1, 2, 3, and 4	No
Secondary	Total sleep time (TST)		Weeks 1, 2, 3, and 4	No
Secondary	Sleep Efficiency		Weeks 1, 2, 3, and 4	No
Secondary	Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening		Weeks 1, 2, 3, and 4	No
Secondary	Quality of sleep		Weeks 1, 2, 3, and 4	No
Secondary	Depth of sleep		Weeks 1, 2, 3, and 4	No
Secondary	Daytime alertness		Weeks 1, 2, 3, and 4	No
Secondary	Ability to concentrate		Weeks 1, 2, 3, and 4	No
Secondary	Physical well-being		Weeks 1, 2, 3, and 4	No
Secondary	Ability to function		Weeks 1, 2, 3, and 4	No
Secondary	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	No
Secondary	Duration of morning stiffness		Weeks 1, 2, 3, and 4	No
Secondary	Pain severity (from IVRS)		Weeks 1, 2, 3, and 4	No
Secondary	Epworth Sleepiness Scale		Weeks 2 and 4	No
Secondary	Insomnia Severity Index		Weeks 2 and 4	No
Secondary	Arthritis Self-Efficacy Scale		Week 4	No
Secondary	SF-36		Week 4	No
Secondary	Physician Clinical Global Impression of treatment		Week 4	No
Secondary	ACR Response Criteria		Week 4	No
Secondary	Percentage of subjects with increase in dose or new prescription of pain medications		Weeks 1, 2, 3, 4	No
Secondary	Percentage of subjects with increase in dose or new prescription of disease modifying medications		Weeks 1, 2, 3, 4	No