Status:
COMPLETED
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) 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® in long term use.
Detailed Description
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.
Eligibility Criteria
Inclusion
- Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
- Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
Exclusion
- Subject terminated early from either study 06-009 or 06-008.
- Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
- Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT00423605
Start Date
December 1 2006
End Date
January 1 2010
Last Update
March 30 2012
Active Locations (91)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Suncoast Internal Medicine Consultants
Auburn, Alabama, United States
3
Arizona Research Center
Phoenix, Arizona, United States, 85023
4
Advanced Clinical Research Institute
Anaheim, California, United States, 92801