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InsomniaPhase 3NCT00367965

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

A Phase 3 study testing Eszopiclone in people with Insomnia and Arthritis, Rheumatoid, run by Sumitomo Pharma America, Inc. at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 25 to 64 years
Conditions the study is for
Insomnia, Arthritis, Rheumatoid
What is being tested?
Eszopiclone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
38 sitesUnited States
Study dates
Feb 2004to Nov 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Study site

    Amarillo, Texas

  • Study site

    Aventura, Florida

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Clearwater, Florida

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Eugene, Oregon

  • Study site

    Everett, Washington

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Hamden, Connecticut

  • Study site

    Huntsville, Alabama

  • Study site

    Kansas City, Kansas

  • Study site

    Lansing, Michigan

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Mayfield Village, Ohio

  • Study site

    Medford, New Jersey

  • Study site

    Memphis, Tennessee

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Norristown, Pennsylvania

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Overland Park, Kansas

  • Study site

    Rochester, New York

  • Study site

    Santa Maria, California

  • Study site

    Sarasota, Florida

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Vero Beach, Florida

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Reading, Pennsylvania

  • Study site

    Whittier, California

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Eszopiclone, placebo
Keywords
Insomnia related to rheumatoid arthritis (RA)
Medical subject headings
Sleep Initiation and Maintenance Disorders, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EszopicloneDrug

    Also called Lunesta, S-zopiclone

    eszopiclone 3 mg

  • placeboDrug

    placebo tablet

Study groups in NCT00367965
Study groupRoleWhat they receive
1Experimentaleszopiclone 3 mg
Receives: Drug: Eszopiclone
2Placebo comparatorplacebo tablet
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean subjective wake time after sleep onset (WASO)

    Measured: Week 1

Secondary outcomes (22)

  1. WASO

    Measured: Weeks 2, 3, and 4

  2. Number of nocturnal awakening

    Measured: Weeks 1, 2, 3, and 4

  3. Total sleep time (TST)

    Measured: Weeks 1, 2, 3, and 4

  4. Sleep Efficiency

    Measured: Weeks 1, 2, 3, and 4

  5. Sleep latency (SL) in subjects with sleep latency of 30 minutes or greater at screening

    Measured: Weeks 1, 2, 3, and 4

  6. Quality of sleep

    Measured: Weeks 1, 2, 3, and 4

  7. Depth of sleep

    Measured: Weeks 1, 2, 3, and 4

  8. Daytime alertness

    Measured: Weeks 1, 2, 3, and 4

  9. Ability to concentrate

    Measured: Weeks 1, 2, 3, and 4

  10. Physical well-being

    Measured: Weeks 1, 2, 3, and 4

  11. Ability to function

    Measured: Weeks 1, 2, 3, and 4

  12. 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

    Measured: Weeks 1, 2, 3, and 4

  13. Duration of morning stiffness

    Measured: Weeks 1, 2, 3, and 4

  14. Pain severity (from IVRS)

    Measured: Weeks 1, 2, 3, and 4

  15. Epworth Sleepiness Scale

    Measured: Weeks 2 and 4

  16. Insomnia Severity Index

    Measured: Weeks 2 and 4

  17. Arthritis Self-Efficacy Scale

    Measured: Week 4

  18. SF-36

    Measured: Week 4

  19. Physician Clinical Global Impression of treatment

    Measured: Week 4

  20. ACR Response Criteria

    Measured: Week 4

  21. Percentage of subjects with increase in dose or new prescription of pain medications

    Measured: Weeks 1, 2, 3, 4

  22. Percentage of subjects with increase in dose or new prescription of disease modifying medications

    Measured: Weeks 1, 2, 3, 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionNov 2004
  4. Study completionNov 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00367965
Sponsor's protocol ID
190-055
Status last verified
Feb 2012
First submitted
23 Aug 2006
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

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.

    PubMed 20098520

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eszopiclone in people with Insomnia and Arthritis, Rheumatoid, run by Sumitomo Pharma America, Inc. at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean subjective wake time after sleep onset (WASO) (time frame: Week 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00367965, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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