Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423813
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2007-01-16
Brief Title:
A Safety and Efficacy Study of Xyrem Sodium Oxybate to Treat Fibromyalgia
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Safety and Efficacy Study of Xyrem Sodium Oxybate in Subjects With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2011-12
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 objective of this trial is to evaluate the safety and efficacy of Xyrem compared to placebo for the treatment of fibromyalgia in a randomized double blind placebo controlled parallel group trial
Detailed Description:
The trial is a randomized double blind placebo controlled parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology Total duration is up to twenty-two 22 weeks of trial participation Subjects will undergo a screening and withdrawalwashout period lasting up to five 5 weeks combined followed by baseline period lasting one 1 week Total treatment duration will be fourteen 14 weeks followed by a two week safety follow-up post treatment period During the screening and withdrawalwashout period no study medication will be given however rescue medication up to 4 grams per day of acetaminophen paracetemol will be allowed
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