A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

PHASE3CompletedINTERVENTIONAL
Enrollment

573

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

June 30, 2009

Conditions
Fibromyalgia
Interventions
DRUG

placebo

Oral Solution

DRUG

Xyrem®

two doses

Trial Locations (116)

11580

North Shore University Hospital, North Shore Pain Services, Valley Stream

14787

Great Lakes Medical Research, Westfield

15009

Tri State Medical Group, Inc., Beaver

16635

Altoona Center for Clinical Research, Duncansville

19067

Founders Research, Yardley

20852

Capital Clinical Research Associates, Rockville

22204

Alben Goldstein, MD, FACP, Arlington

27103

The Center for Clinical Research, Winston-Salem

27834

Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU, Greenville

29204

Southern Orthopaedic Sports Medicine, Columbia

30066

Drug Studies America, Marietta

32257

Florida Institute of Medical Research, Jacksonville

32610

Center for Musculoskeletal Pain Research, Gainesville

32778

Lake Rheumatology, Tavares

32806

Compass Research, Orlando

32962

Center for Arthritis and Rheumatism, Vero Beach

33155

AppleMed Research, Miami

33542

Florida Medical Clinic, P.A., Clinical Research Division, Zephyrhills

33614

Tampa Medical Group, P.A., Tampa

33707

Clinical Research Group of St. Petersburg, Inc., St. Petersburg

33773

Suncoast Internal Medicine Consultants, Largo

35209

Capstone Clinical Trials, Inc., Birmingham

36106

Drug Research and Analysis Corporation, Montgomery

36830

East Alabama Arthritis Center, Auburn

39402

Arthritis Associates, Hattiesburg

40509

Central Kentucky Research Associates,Inc., Lexington

42303

Bluegrass Internal Medicine, Owensboro

42701

Center for Arthritis and Osteoporosis, Elizabethtown

43210

Ohio State U, Immunology/Rheumatology William Davis Medical Research Center, Columbus

44121

Health Research Associates, LLC (HRA), Cleveland

44130

Cleveland Neuro-Sleep Research Institute Inc., Middleburg Heights

45224

Hightop Medical Research Center, Cincinnati

46254

Investigative Clinical Research of Indiana, LLC, Indianapolis

48025

Quest Research Institute, Bingham Farms

49601

Professional Clinical Research, Cadillac

49616

Professional Clinical Research at Cyrstal Lake Health Center, Benzonia

49643

Professional Clinical Research at Crystal Lake Health Center, Interlochen

60641

Fibromyalgia Treatment Centers of America, Chicago

63117

Medex Healthcare Research, Inc, St Louis

63141

St. John's Mercy Health System, St Louis

66606

Cotton-O'neil Clinical Research center, Topeka

68114

Quality Clinical Research, Inc., Omaha

70809

Louisiana Sleep Foundation, Baton Rouge

76108

DFW Wellness, Fort Worth

76708

Arthritis and Osteoporosis Clinic, Research Center of Central Texas, Waco

77030

The Methodist Hospital System, Houston

77063

Houston Sleep Center, Houston

77074

R/D Clinical Research, Inc., Houston

77479

Clinical Health Research, LLC, Sugarland

78215

Sun Research Institute, San Antonio

78229

University of Texas Health Science Center, San Antonio

78232

Arthritis & Osteoporosis Center of South Texas, San Antonio

78756

Neurology Future Research Trials, Austin

83814

Coeur d'Alene Arthritis Clinic, Coeur d'Alene

85004

dba 21st Century Neurology, Phoenix

87109

Albuquerque Neuroscience, Inc., Albuquerque

91325

Northridge Neurological Center, Northridge

91505

Providence Clinical Research, Burbank

92618

Nerve Pro Research, Irvine

92801

Orange County Clinical Trials, Anaheim

92835

North Orange County Research Institute, Inc., Fullerton

93449

Arroyo Medical Group, Pismo Beach

95628

Med Investigations, Inc., Fair Oaks

95821

Northern California Research, Sacramento

95825

Sacramento Research Medical Group, Sacramento

97210

Summit Research Network (Oregon) Inc., Portland

97239

Oregon Health Sciences University School of Medicine, Portland

06030-1310

University of CT, Health Center, Farmington

08009

Comprehensive Clinical Research, Berlin

08816

Alan Lichtbroun, MD, East Brunswick

28607-0000

Appalachian Regional Medical Associates, Boone

Unknown

Rhumatologie, Amiens

CHU de Grenoble-hopital Sud, Échirolles

Hopital Claude Huriez Service de medecine Interne, Lille

Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord, Nantes

Hopital Pasteue - Pavillon O, Nice

Hopital Hotel Dieu service de medecine interne, Paris

CHU Hopital de Rangueil, Toulouse

Schlosspark-Klinik, Berlin

Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie, Böblingen

Intensivmedizin der Uniklinik Koln, Cologne

Praxis Dr. Wiedeking, Essen

Praxis fur Innere Medizin und Rheumatologie, Gräfelfing

Gemeinschaftspraxis Schmerzzentrum, Hamburg

Rheumazentrum am Krankenhaus Bad Doberan, Hohenfelde - Bad Doberan

Praxisklinik Dr. Weiss, Mannheim

Praxis Dr. Sohn, Schwalmtal

Azienda Ospedaliera Luigi Sacco, Milan

Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara, Pisa

Amphia Ziekenhuis, Breda

Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis, Enschede

Wojewodzki Szpital Zespolony, Elblag

Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny, Katowice

Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny, Poznan

w Szczecinie, Szczecinie

NZOZ Nasz Lekarz, Torun

Instytut Reumatologii, Warsaw

Hospital Santa Creu i Sant Pau, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

Instituto Ferran de Reumatologia, Barcelona

Hospital Universitario de Guadalajara, Guadalajara

Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

Hospital Civil de malaga, Málaga

Hospital Central de Asturias, Oviedo

Hospital Universitario de Canarias, San Cristóbal de La Laguna

Hospital Clinico Universitario de Santiago, Santiago de Compostela

Lever Chambers Centre for Health, Bolton

4 West Kennedy Clinical Trial unit, London

King College London, London

Freeman Hospital, Newcastle upon Tyne

Poole General Hospital, Poole

S75 2EP

Barnsley District General Hospital, Rheumatology Department, Barnsley

BA1 1RL

Royal National Hospital for Rheumatic Diseases NHS, Bath

SE5 9RJ

King's College London, London

NE7 7DN

Freeman Hospital, Newcastle

BH15 2JB

Philip Arnold Unit, Poole

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY