195
Participants
Start Date
July 31, 2004
Primary Completion Date
April 30, 2005
Study Completion Date
January 31, 2006
Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.
Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
Placebo
Placebo one of two doses matching active treatment by volume for 8 weeks.
Altoona Center for Clinical Research, Duncansville
C.A.R.E. Center, Raleigh
Duke University Medical Center, Durham
Alvin Daughtridge Arthritis Center, Lenoir
Miami Research Associates, Miami
Radiant Research, Inc., West Palm Beach
Central Kentucky Research Associates, Inc., Lexington
Cleveland Sleep Center, Middlebrook Heights
Lynn Health Science Institute, Oklahoma City
Abigail Rebecca Neiman, MD, Katy
The University of Texas Health Science Center, San Antonio
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital, Sandy City
Radiant Research, Scottsdale
Wallace Rheumatic Study Center, Los Angeles
Osteoporosis Medical Center, Beverly Hills
Oregon Health and Science University, Portland
Pacific Rheumatology Research, Inc., Renton
Seattle Rheumatology Associates, Seattle
LSU Health Sciences Center, Shreveport
Richard N. Podell, MD, Springfield
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY