Study of the Insomnia in Patients With Low Back Pain
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Back Pain; Low Back Pain
Intervention: Eszopiclone; Placebo
Intervention description: Eszopiclone 3 mg po nightly for duration of study blind phase.; Placebo nightly over duration of double blind study phase
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Insomnia; Low Back Pain; Hypnotics; Eszopiclone; Pain; Disability

Summary:

      The purpose of this study is to examine whether insomnia due to chronic low back pain can
      improve with use of eszopiclone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Diagnosis of insomnia based on DSM-IV criteria for insomnia due to a general medical
             condition (low-back pain);

               -  The insomnia must not predate the onset of low-back pain by more than 1 month;

               -  Usual nightly TST (Total Sleep Time) < 6.5 hours and/or usual SOL (Sleep Onset
                  Latency) > 30 minutes for the last month prior to screening;

               -  ISI (Insomnia Severity Index) > 14 (at least moderate insomnia);

               -  Age 21-64 years;

               -  Greater than 40 on VAS (Visual Analog Scale) for pain (scale is 0-no pain to
                  100-worst imaginable pain);

               -  Patient Global Impression of Pain of at least 3 (on a 1-5 scale, indicating at
                  least moderate severity);

               -  reported Back pain must be greater than reported leg pain, and there must be no
                  signs of spinal nerve root compression;

               -  presence of normal motor strength on exam;

               -  duration of chronic low back pain of greater than three months;

               -  low back pain location must be inferior to T12 and superior to the gluteal fold.

        Exclusion Criteria:

          -  • Significant medical or neurological illness in excess of that which is directly
             responsible for the chronic low back pain;

               -  the presence of an active and significant psychiatric disease with a substantive
                  impact on sleep;

               -  meeting DSM-IV criteria for an Axis I disorder within the last three months, or
                  meeting criteria for substance abuse within the last 12 months;

               -  current pregnancy; history of hypersensitivity, intolerance, or contraindication
                  to Naproxen/Lansoprazole or Eszopiclone;

               -  baseline creatinine of 2.0 or greater; patient taking other medications having
                  significant renal effects (e.g. lithium, ACE inhibitor, angiotensin receptor
                  antagonist, or thiazide/loop diuretics);

               -  patients taking other anticoagulants; patients having an allergy to aspirin;
                  history of diagnosed gastric or duodenal ulcer;

               -  history of bleeding or clotting diathesis; lifetime history of myocardial
                  infarction or cerebrovascular accident;

               -  Elevated PT/PTT/INR (Prothrombin Time, Partial Thromboplastin Time, International
                  Normalized Ratio)at screening;

               -  Abnormal kidney function detected in screening labs;

               -  history of back related surgery within the past 3 months; history of
                  corticosteroid use in the past 30 days;

               -  presence of currently pending litigation or worker's compensation claim related
                  to the chronic low back pain;

               -  inability to follow study procedures or complete the study; or the use of any
                  medications that could affect sleep within 5 half-lives of screening;

               -  history of back surgery within the past 2 years with the exception of a
                  discectomy;

               -  pregnant or lactating females;

               -  women of child-bearing potential who will not agree to use approved means of
                  birth control during the trial;

               -  history of any surgery within the past one month; history of any major physical
                  trauma within the last 6 months;

               -  history of corticosteroid use within the last 90 days; diagnosis of rheumatoid or
                  psoriatic arthritis;

               -  history of fibromyalgia;

               -  presence of spondyloarthropathy;

               -  presence of sciatica;

               -  spinal stenosis;

               -  presence of any vertebral fractures, spondylolisthesis; or radicular back pain.