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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00367965
Other study ID # 190-055
Secondary ID
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


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
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