Status:
COMPLETED
A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tri...
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 ...
Eligibility Criteria
Inclusion
- Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
Exclusion
- Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
- Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
548 Patients enrolled
Trial Details
Trial ID
NCT00371137
Start Date
August 1 2006
End Date
December 1 2008
Last Update
December 29 2011
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Rheumatology Associates of N. AL, PC
Huntsville, Alabama, United States, 35801
3
Xenoscience, Inc. dba 21st Century Neurology
Phoenix, Arizona, United States, 85004
4
Arizona Research Center
Phoenix, Arizona, United States, 85023