Study of the Insomnia in Patients With Low Back Pain

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.