Overview

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.