Status:
COMPLETED
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat 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 :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT00423813
Start Date
December 1 2006
End Date
June 1 2009
Last Update
January 24 2012
Active Locations (116)
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1
East Alabama Arthritis Center
Auburn, Alabama, United States, 36830
2
Capstone Clinical Trials, Inc.
Birmingham, Alabama, United States, 35209
3
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
4
dba 21st Century Neurology
Phoenix, Arizona, United States, 85004