Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365976
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2006-08-16
Brief Title:
Study of the Insomnia in Patients With Low Back Pain
Sponsor:
Duke University
Organization:
Duke University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Comparisons 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
Comparisons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ESRC 032 | None | None | None |