Study of the Insomnia in Patients With Low Back Pain

NCT00365976 | Completed Phase 4 Results

• 2 other identifiers: Pro00011697ESRC 032
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Insomnia

Keywords

Insomnia; Low Back Pain; Hypnotics; Eszopiclone; Pain; Disability

Outcome Measures

Primary Outcomes (1)

• Mean Subjective Sleep Diary Derived Total Sleep Time (TST)

  Nightly total sleep time was averaged from diary entries.

  Postnaprosyn baseline, Week 1, week 2, week 4

Secondary Outcomes (11)

• Visual Analog Scale Pain Ratings (VAS)

  Postnaprosyn baseline, Week 1, Week 2, Week 4

• Mean Sleep Onset Latency (SOL)

  Postnaprosyn Baseline, Week 1, Week 2 week 4

• Wake Time After Sleep Onset

  Postnaprosyn Baseline, Week 1, Week 2 week 4

• Number of Awakenings

  Postnaprosyn Baseline, Week 1, Week 2 week 4

• Sleep Quality Ratings

  Postnaprosyn Baseline, Week 1, Week 2 week 4

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

ACTIVE COMPARATOR

Eszopiclone

Drug: Eszopiclone

Interventions

Eszopiclone DRUG

Eszopiclone 3 mg po nightly for duration of study blind phase.

Also known as: Lunesta

2

Placebo DRUG

Placebo nightly over duration of double blind study phase

1

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Duke University: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (18)

• Berry H, Bloom B, Hamilton EB, Swinson DR. Naproxen sodium, diflunisal, and placebo in the treatment of chronic back pain. Ann Rheum Dis. 1982 Apr;41(2):129-32. doi: 10.1136/ard.41.2.129.

  PMID: 6462116 BACKGROUND

• Benca RM, Ancoli-Israel S, Moldofsky H. Special considerations in insomnia diagnosis and management: depressed, elderly, and chronic pain populations. J Clin Psychiatry. 2004;65 Suppl 8:26-35.

  PMID: 15153065 BACKGROUND

• Coats TL, Borenstein DG, Nangia NK, Brown MT. Effects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial. Clin Ther. 2004 Aug;26(8):1249-60. doi: 10.1016/s0149-2918(04)80081-x.

  PMID: 15476906 BACKGROUND

• Curran MP, Wellington K. Delayed-release lansoprazole plus naproxen. Drugs. 2004;64(17):1915-9; discussion 1920-1. doi: 10.2165/00003495-200464170-00008.

  PMID: 15329041 BACKGROUND

• Edinger JD, Means MK, Stechuchak KM, Olsen MK. A pilot study of inexpensive sleep-assessment devices. Behav Sleep Med. 2004;2(1):41-9. doi: 10.1207/s15402010bsm0201_4.

  PMID: 15600223 BACKGROUND

• Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24.

  PMID: 12592542 BACKGROUND

• Holm I, Friis A, Storheim K, Brox JI. Measuring self-reported functional status and pain in patients with chronic low back pain by postal questionnaires: a reliability study. Spine (Phila Pa 1976). 2003 Apr 15;28(8):828-33.

  PMID: 12698128 BACKGROUND

• Katz N, Rodgers DB, Krupa D, Reicin A. Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials. Curr Med Res Opin. 2004 May;20(5):651-8. doi: 10.1185/030079904125003160.

  PMID: 15140330 BACKGROUND

• Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials. Ann Rheum Dis. 1997 Apr;56(4):214-23. doi: 10.1136/ard.56.4.214.

  PMID: 9165992 BACKGROUND

• Krystal AD, Walsh JK, Laska E, Caron J, Amato DA, Wessel TC, Roth T. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep. 2003 Nov 1;26(7):793-9. doi: 10.1093/sleep/26.7.793.

  PMID: 14655910 BACKGROUND

• Lai KC, Lam SK, Chu KM, Hui WM, Kwok KF, Wong BC, Hu HC, Wong WM, Chan OO, Chan CK. Lansoprazole reduces ulcer relapse after eradication of Helicobacter pylori in nonsteroidal anti-inflammatory drug users--a randomized trial. Aliment Pharmacol Ther. 2003 Oct 15;18(8):829-36. doi: 10.1046/j.1365-2036.2003.01762.x.

  PMID: 14535877 BACKGROUND

• Luo X, Pietrobon R, Curtis LH, Hey LA. Prescription of nonsteroidal anti-inflammatory drugs and muscle relaxants for back pain in the United States. Spine (Phila Pa 1976). 2004 Dec 1;29(23):E531-7. doi: 10.1097/01.brs.0000146453.76528.7c.

  PMID: 15564901 BACKGROUND

• Ostelo RW, de Vet HC. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):593-607. doi: 10.1016/j.berh.2005.03.003.

  PMID: 15949778 BACKGROUND

• Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.

  PMID: 15370723 BACKGROUND

• Rives PA, Douglass AB. Evaluation and treatment of low back pain in family practice. J Am Board Fam Pract. 2004 Nov-Dec;17 Suppl:S23-31. doi: 10.3122/jabfm.17.suppl_1.s23.

  PMID: 15575027 BACKGROUND

• Smith MT, Haythornthwaite JA. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev. 2004 Apr;8(2):119-32. doi: 10.1016/S1087-0792(03)00044-3.

  PMID: 15033151 BACKGROUND

• Zammit GK, McNabb LJ, Caron J, Amato DA, Roth T. Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia. Curr Med Res Opin. 2004 Dec;20(12):1979-91. doi: 10.1185/174234304x15174.

  PMID: 15701215 BACKGROUND

• Goforth HW, Preud'homme XA, Krystal AD. A randomized, double-blind, placebo-controlled trial of eszopiclone for the treatment of insomnia in patients with chronic low back pain. Sleep. 2014 Jun 1;37(6):1053-60. doi: 10.5665/sleep.3760.

  PMID: 24882900 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Low Back Pain; Pain

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Limitations and Caveats

1. We obtained only self-reported sleep outcomes. 2. The period of double-blind treatment was relatively short. 3. We excluded all subjects who might have required opioid therapy to manage their pain which limits study generalizability.

Results Point of Contact

• Title: Jenny Bridgers, CRC
• Organization: Duke University

jenny.bridgers@duke.edu

919-684-0752

Study Officials

• Andrew D Krystal, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2006
• First Posted: August 18, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 24, 2015
• Results First Posted: June 7, 2013

Record last verified: 2015-06

Locations

US (1)