Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087555
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2004-07-12
Brief Title:
Trial Comparing the Effects of Xyrem Sodium Oxybate With Placebo for the Treatment of Fibromyalgia
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Parallel-Group Multi-Center Trial Comparing the Effects of Orally Administered XyremR Sodium Oxybate With Placebo for the Treatment of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2012-01
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 determine whether Xyrem sodium oxybate is effective when used alone to treat the pain and sleep disturbances of fibromyalgia
Detailed Description:
Fibromyalgia affects millions of Americans yet there are no FDA approved drugs to treat this debilitating condition Besides causing pain it also disrupts normal sleep patterns in many of its victims Pain and lack of sleep reinforce each other making patients progressively more miserable Xyrem is a potent hypnotic that induces and consolidates sleep In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients This trial is designed to test this hypothesis Patients who enroll in this study will stop taking any prescription medications for fibromyalgia over-the-counter pain relievers will be permitted They will then take either Xyrem alone or placebo alone Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase
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