Study of the Insomnia in Patients With Low Back Pain

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Sunovion
• Treatments: Eszopiclone

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.