Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392041
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2006-10-24
Brief Title:
Eszopiclone in the Treatment of Insomnia and Fibromyalgia
Sponsor:
Lesley A Allen PhD
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2020-12
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 is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time sleep quality pain fatigue physical functioning and emotional distress than will those receiving placebo
Detailed Description:
Fibromyalgia FM is a prevalent debilitating and costly syndrome Although the pathophysiology of FM is not yet well-understood sleep disturbance is a prominent feature of most theories Eszopiclone has been approved by the FDA for the treatment of insomnia but has not been studied in the treatment of FMS The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia FMS in FMS patients Participants will be randomly selected to receive eszopiclone or placebo It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time sleep quality pain fatigue physical functioning and emotional distress than will those receiving 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