Primary InsomniaPhase 4NCT00365976
Study of the Insomnia in Patients With Low Back Pain
A Phase 4 study testing Eszopiclone in people with Primary Insomnia, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Eszopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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);
Show all 11Show fewer
- 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.
Who cannot join
- • 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;
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
Read the 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 with enormous health-care and productivity costs, reduced quality of life, and limitation of function and is almost universally associated with insomnia (Rives and Douglas, 2004). While it had long been believed that insomnia was a symptom of pain conditions and of little consequence in its' own right, a growing literature suggests that insomnia has important effects on the clinical course of pain syndromes (Smith and Haythornthwaite, 2004). While pain may disrupt sleep, it appears that problems with sleep increase pain and are associated with impairments in daytime function. The emerging point of view is that specific treatment for both pain and insomnia is needed for optimal clinical management (Smith and Haythornthwaite, 2004). Surprisingly, despite the fact that chronic low-back pain is the most common pain condition, the treatment of insomnia in this disease has never been studied. As a result, we propose to carry out the first double-blind placebo-controlled study of the treatment insomnia in patients with chronic low back pain.
Comparison(s): We will test the hypothesis that treating the insomnia with eszopiclone 3 mg (ESZ) along with management of pain with naproxen 500 mg bid (NAP) will result in statistically significantly improved sleep compared with placebo. We also propose to test as a secondary hypothesis that treatment with ESZ will lead to significant improvement in pain and daytime function vs. placebo.
- Conditions
- Primary Insomnia
- Being tested
- Eszopiclone, Placebo
- Keywords
- Insomnia, Low Back Pain, Hypnotics, Eszopiclone, Pain, Disability
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EszopicloneDrug
Also called Lunesta
Eszopiclone 3 mg po nightly for duration of study blind phase.
PlaceboDrug
Placebo nightly over duration of double blind study phase
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Active comparator | Eszopiclone Receives: Drug: Eszopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
Nightly total sleep time was averaged from diary entries.
Measured: Postnaprosyn baseline, Week 1, week 2, week 4
Secondary outcomes (11)
Visual Analog Scale Pain Ratings (VAS)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Measured: Postnaprosyn baseline, Week 1, Week 2, Week 4
Mean Sleep Onset Latency (SOL)
Measured: Postnaprosyn Baseline, Week 1, Week 2 week 4
Wake Time After Sleep Onset
Measured: Postnaprosyn Baseline, Week 1, Week 2 week 4
Number of Awakenings
Measured: Postnaprosyn Baseline, Week 1, Week 2 week 4
Sleep Quality Ratings
Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep
Measured: Postnaprosyn Baseline, Week 1, Week 2 week 4
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia).
Measured: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4
Patient Global Impression of Pain Ratings
Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)
Measured: postnaprosyn Baseline, Week 1, Week 2 week 4
Roland Morris Low Back Pain Inventory (RMLBPI)
The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 "yes-no" items assessing potential disabilities.
Scores range from 0 (no disability) to 24 (severe disability).
Measured: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Hamilton Depression Rating Scale (HAM-D-24)
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Measured: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Measured: Baseline, week 1, week 2, week 4
State-Trait Anxiety Inventory (STAI)
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)
Measured: Baseline, week 1, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew D Krystal, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365976
- Sponsor's protocol ID
- Pro00011697
- Other IDs
- ESRC 032
- Status last verified
- Jun 2015
- First submitted
- 16 Aug 2006
- Last updated
- 24 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 6462116Benca 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.
PubMed 15153065Coats 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.
PubMed 15476906Curran MP, Wellington K. Delayed-release lansoprazole plus naproxen. Drugs. 2004;64(17):1915-9; discussion 1920-1. doi: 10.2165/00003495-200464170-00008.
PubMed 15329041Edinger 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.
PubMed 15600223Hagg 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.
PubMed 12592542Holm 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.
PubMed 12698128Katz 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.
PubMed 15140330Koes 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.
PubMed 9165992Krystal 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.
PubMed 14655910Lai 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.
PubMed 14535877Luo 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.
PubMed 15564901Ostelo 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.
PubMed 15949778Pallay 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.
PubMed 15370723Rives 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.
PubMed 15575027
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00365976
- Acronym / sponsor ID
- Pro00011697
- Conditions
- Primary Insomnia
- Keywords
- Insomnia, Low Back Pain, Hypnotics, Eszopiclone, Pain, Disability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Aug 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Aug 2006 (estimated)
- Results
- Posted 7 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with enormous health-care and productivity costs, reduced quality of life, and limitation of function and is almost universally associated with insomnia (Rives and Douglas, 2004). While it had long been believed that insomnia was a symptom of pain conditions and of little consequence in its' own right, a growing literature suggests that insomnia has important effects on the clinical course of pain syndromes (Smith and Haythornthwaite, 2004). While pain may disrupt sleep, it appears that problems with sleep increase pain and are associated with impairments in daytime function. The emerging point of view is that specific treatment for both pain and insomnia is needed for optimal clinical management (Smith and Haythornthwaite, 2004). Surprisingly, despite the fact that chronic low-back pain is the most common pain condition, the treatment of insomnia in this disease has never been studied. As a result, we propose to carry out the first double-blind placebo-controlled study of the treatment insomnia in patients with chronic low back pain.
Comparison(s): We will test the hypothesis that treating the insomnia with eszopiclone 3 mg (ESZ) along with management of pain with naproxen 500 mg bid (NAP) will result in statistically significantly improved sleep compared with placebo. We also propose to test as a secondary hypothesis that treatment with ESZ will lead to significant improvement in pain and daytime function vs. placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Active comparator | Drug: EszopicloneEszopiclone |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- • Diagnosis of insomnia based on DSM-IV criteria for insomnia due to a general medical condition (low-back pain);
Key exclusion criteria (22 listed)
- • Significant medical or neurological illness in excess of that which is directly responsible for the chronic low back pain;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EszopicloneAlso: LunestaEszopiclone 3 mg po nightly for duration of study blind phase. | Drug | 2 |
| PlaceboPlacebo nightly over duration of double blind study phase | Drug | 1 |
Primary outcome
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
Time frame: Postnaprosyn baseline, Week 1, week 2, week 4
Nightly total sleep time was averaged from diary entries.
11 secondary outcomes
Visual Analog Scale Pain Ratings (VAS)
Time frame: Postnaprosyn baseline, Week 1, Week 2, Week 4
Mean Sleep Onset Latency (SOL)
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Wake Time After Sleep Onset
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Number of Awakenings
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Sleep Quality Ratings
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Insomnia Severity Index (ISI)
Time frame: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4
Patient Global Impression of Pain Ratings
Time frame: postnaprosyn Baseline, Week 1, Week 2 week 4
Roland Morris Low Back Pain Inventory (RMLBPI)
Time frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Hamilton Depression Rating Scale (HAM-D-24)
Time frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Baseline, week 1, week 2, week 4
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, week 1, week 2, week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6462116Berry 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.
- Background: PubMed 15153065Benca 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.
- Background: PubMed 15476906Coats 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.
- Background: PubMed 15329041Curran MP, Wellington K. Delayed-release lansoprazole plus naproxen. Drugs. 2004;64(17):1915-9; discussion 1920-1. doi: 10.2165/00003495-200464170-00008.
- Background: PubMed 15600223Edinger 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.
- Background: PubMed 12592542Hagg 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.
- Background: PubMed 12698128Holm 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.
- Background: PubMed 15140330Katz 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.
- Background: PubMed 9165992Koes 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.
- Background: PubMed 14655910Krystal 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.
- Background: PubMed 14535877Lai 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.
- Background: PubMed 15564901Luo 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.
Related trials for Primary Insomnia
Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
Chronic Back Pain, Chronic Pain
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Krystal, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eszopiclone in people with Primary Insomnia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Subjective Sleep Diary Derived Total Sleep Time (TST) (time frame: Postnaprosyn baseline, Week 1, week 2, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365976, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.