Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

PHASE3CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

July 31, 2010

Conditions
Fibromyalgia
Interventions
DRUG

Sodium Oxybate

4.5 grams per night taken in two equally divided doses

DRUG

Sodium Oxybate & 6 Tablets

4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night

DRUG

Sodium Oxybate & 8 Tablets

6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night

DRUG

Sodium Oxybate Oral Solution (6 grams)

6 grams per night taken in two equally divided doses

Trial Locations (32)

16635

Altoona Center for Clinical Research, Duncansville

17055

Central Pennsylvania Clinic, Mechanicsburg

27103

The Center for Clinical Research, Winston-Salem

29204

Southern Orthopeadic Sports, Columbia

29732

The Carolina Center for Rheumatology & ArthiritisCare PA, Rock Hill

32806

Compass Research, Orlando

33916

Clinical Physiology Associates Clinical Study, Fort Meyers

37421

Clinsearch, Chattanooga

42101

Graves Gilbert Clinic, Bowling Green

42431

Commonwealth Biomedical Resaerch, LLC, Madisonville

45224

Hill Top Physicians Inc. / Hihgtop Medical Research Center, Cincinnati

46601

Memorial Medical Group - Clinical Research, South Bend

49643

Professional clinical Research - Interlochen, Interlochen

68114

Quality Clinical Research, Inc, Omaha

70809

Louisiana Sleep Foundation, Baton Rouge

76108

DFW Wellness, Fort Worth

77063

Houston Sleep Clinic, Houston

77479

Clinical Health Research, LLC, Sugar Land

78215

Sun Research Institute, San Antonio

78756

FutureSearch Trials of Neurology, Austin

85004

Dba 21st Century Neurology, Phoenix

85023

Arizona Research Center, Phoenix

87109

Albuquerque Neuroscience, Inc., Albuquerque

91325

Northridge Neurological Center, Northridge

92705

Apex Research Institute, Santa Ana

92801

Advanced Clinical Research Institute, Anaheim

Orange County Clinical Trials, Anaheim

93449

Arroyo Medical Group, Inc., Pismo Beach

95628

Med Investigations, Inc., Fair Oaks

95821

Northern California Research, Sacramento

95825

Superior Research, LLC, Sacramento

98055

Pacific Rheumatology Associates, Renton

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY