Status:
COMPLETED
Study of the Insomnia in Patients With Low Back Pain
Lead Sponsor:
Duke University
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Primary Insomnia
Eligibility:
All Genders
21-64 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
Detailed Description
There is a great need to develop effective treatments for insomnia in patients with chronic low-back pain. Chronic low-back pain is among the most prevalent of all health complaints, is associated wit...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00365976
Start Date
August 1 2006
End Date
September 1 2010
Last Update
July 24 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710