Study of the Insomnia in Patients With Low Back Pain
CompletedPhase 4NCT00365976
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
Study details
- Official title
- Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain
- Conditions
- Primary Insomnia
- Interventions
- Drug: Eszopiclone
- Drug: Placebo
- Sponsor
- Duke University
- Collaborators
- Sumitomo Pharma America, Inc.
- Start date
- 2006-08
- Primary completion
- 2010-09
- Sex
- All
- Age range
- from 21 Years to 64 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 su…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00365976