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Insomnia and Osteoarthritis Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374556
First Posted: September 11, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael T. Smith, Ph.D, Johns Hopkins University
  Purpose
This research is being done to evaluate the effects of a sleeping pill (eszopiclone, Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in patients with knee pain.

Condition Intervention
Osteoarthritis Insomnia Drug: eszopiclone, 2 mg, qhs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by Michael T. Smith, Ph.D, Johns Hopkins University:

Primary Outcome Measures:
  • Two-week average sleep diary and actigraphy measures of Wake After Sleep Onset Time; measured at six weeks.
  • Laboratory Pain Sensitivity Measures; levels at six weeks.
  • Two-week average diary ratings of pain severity; score at six weeks.

Secondary Outcome Measures:
  • WOMAC Disability & Joint Stiffness Indices; measured at 12 weeks.
  • Quality of Life (SF-36); measured at 12 weeks.
  • Insomnia Severity Index; measured at 12 weeks.

Estimated Enrollment: 64
Study Start Date: January 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-64
  • Diagnosed with and under physicians care for osteoarthritis of the knee according to American College of Rheumatology Criteria with radiographic evidence demonstrating at least grade 1 OA
  • Report at least typical arthritic pain>4 out of 10 (0=no pain, 10=the most extreme pain imaginable)
  • Meet DSM-IV and ICSD-R criteria for either primary (psychophysiologic) insomnia or insomnia secondary to osteoarthritis
  • Insomnia symptoms must include problems with middle of the night awakenings
  • Insomnia symptom duration > 6 months
  • Baseline, 2-week, sleep diary average wake after sleep onset time >30 minutes
  • Baseline self-reported total sleep time < 6.5 hours per night
  • Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study

Exclusion Criteria:

  • Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc)
  • Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc)
  • Major medical disease (including, hepatic impairment, chronic obstructive pulmonary disease/compromised respiratory function, cancer, dementia, diabetes, congestive heart failure, cerebrovascular disease, raynaud's syndrome)
  • Active major psychiatric disorders (including dementia or cognitive impairment) and history of schizophrenia or bipolar I disorder
  • History of serious suicide attempt; 6) history of alcohol or substance (including prescription medications) abuse
  • Pregnancy or plans to become pregnant within 6 months
  • Intraarticular steroid injection within the past month
  • Regular (>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers, within the past two months
  • Regular (> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and anticonvulsants within the past one month
  • Unwilling or unable to discontinue all use of the medications listed in #10 for two weeks prior to starting the study
  • Unwilling or unable to discontinue all centrally acting agents and all analgesic usage within 24 hours of pain testing sessions
  • Refusal to provide consent to contact patient's physician to establish diagnosis and obtain medical record information
  • Regular tobacco or nicotine use
  • Heavy caffeine use [(>2 cups of coffee/day (equivalent)
  • History of previous allergic reaction or severe side effects to sedative hypnotics
  • Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir)
  • In addition, subjects will undergo in-laboratory blood tests prior to receiving drug and will be excluded from further participation if they exhibit: a) positive pregnancy test, b) positive toxicology (benzodiazepine, opioids, THC, alcohol, and stimulants), c) abnormal liver enzyme panel
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374556


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Michael T. Smith, Ph.D. Johns Hopkins University
  More Information

Responsible Party: Michael T. Smith, Ph.D, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00374556     History of Changes
Other Study ID Numbers: NA_00001703
First Submitted: September 8, 2006
First Posted: September 11, 2006
Last Update Posted: October 12, 2017
Last Verified: March 2014

Keywords provided by Michael T. Smith, Ph.D, Johns Hopkins University:
eszopiclone
insomnia

Additional relevant MeSH terms:
Osteoarthritis
Sleep Initiation and Maintenance Disorders
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs