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Completed Phase 3 Interventional Results available

Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

ClinicalTrials.gov ID: NCT00423605

Public ClinicalTrials.gov record NCT00423605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Study identification

NCT ID
NCT00423605
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
560 participants

Conditions and interventions

Conditions

Interventions

  • Xyrem® Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2006
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009
Last update posted
Mar 29, 2012

2006 – 2010

United States locations

U.S. sites
66
U.S. states
27
U.S. cities
63
Facility City State ZIP Site status
Pinnacle Research Group, LLC Anniston Alabama 36207
Suncoast Internal Medicine Consultants Auburn Alabama
Arizona Research Center Phoenix Arizona 85023
Advanced Clinical Research Institute Anaheim California 92801
Orange County Clinical Trials Anaheim California
Northern California Research Carmichael California 95608
Med Investigations Inc. Fair Oaks California
Nerve Pro Research Irvine California
Arroyo Medical Group, Inc. Pismo Beach California 93449
AppleMed Research Miami Florida
Compass Research Orlando Florida 32806
Sunrise Medical Research Plantation Florida 33317
Clinical Research Group of St. Petersburg, Inc St. Petersburg Florida
Tampa Medical Group, P.A. Tampa Florida
Center for Arthiritis and Rheumatism Vero Beach Florida
Florida Medical Clinic, P.A. Zephyhills Florida
Drug Studies America Marietta Georgia
Coeur d' Alene Arthritis Clinic Coeur d'Alene Idaho
Fibromyalgia Treatment Centers of America Chicago Illinois
Deerpath Physcians Group Gurnee Illinois 60031
Balanced Health Research Center Peoria Illinois 61614
Graves - Gilbert Clinic Bowling Green Kentucky 42101
Center for Arthiritis & Osteoporosis Elizabethtown Kentucky
Central Kentucky Research Associates, Inc. Lexington Kentucky 40509
Commonwealth Biomedical Research, LLC Madisonville Kentucky 42431
Louisiana Sleep Foundation Baton Rouge Louisiana
Capital Clinical Rsearch Asociates Rockville Maryland
FutureCare Studies Springfield Massachusetts 01103
Clinical Pharmacology Study Group Worcester Massachusetts 01610
Professional Clinical Research, Inc. at Crystal Lake Health Center Benzonia Michigan
Professional Clinical Research Cadillac Michigan
Professional Clinical Research at Crystal Lake Health Center Interlocken Michigan 49643
PCM Medical Services Lansing Michigan 48917
Clinvest Springfield Missouri 65807
School of Osteopathic Medicine Cherry Hill New Jersey 08002
Anderson & Collins Clinical Research, Inc. Edison New Jersey 08817
Upstate Clinical Research, LLC Albany New York 12205
AAIR Research Center Rochester New York 14618
North Shore University Hospital Valley Stream New York
Appalachian Regional Medical Associates Boone North Carolina
Carolina Bone and Joint Charlotte North Carolina 28210
Duke University Medical Center Durham North Carolina 27103
Wake Research Associates, LLC Raleigh North Carolina 27612
The Center for Clinical Research Winston-Salem North Carolina 27103
Hill Top Physicians Inc./Hightop Medical Research Center Cincinnati Ohio
Radiant Research Mogadore Ohio 44260
Tulsa Clinical Research, LLC Tulsa Oklahoma 74104
PRO Research Eugene Oregon 97401
School of Nursing Portland Oregon
Tri State Medical Group, Inc. Beaver Pennsylvania 15009
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
Central Pennsylvania Clinical Research Mechanicsburg Pennsylvania 17055
Omega Medical Research Warwick Rhode Island 02886
Low Country Research Country Charleston South Carolina 29406
Southern Orthopaedic Sports Medicine Columbia South Carolina
Radiant Research, Greer Greer South Carolina 29651
Rheumatology Consultants, PLLC Knoxville Tennessee 37909
Walter F. Chase, MD PA Austin Texas 78705
R/D Clinical Research, Inc. Houston Texas 77074
Sun Research Institute San Antonio Texas 78205
Radiant Research San Antonio Northeast San Antonio Texas 78217
The University of Texas Health Science San Antonio Texas 78229
Fatigue Consultation Center Salt Lake City Utah 84102
Evergreen Hospital Medical Center Kirkland Washington 98034
Pacific Rheumatology Associates, Inc. Renton Washington 98055
Charleston Internal Medicine Charleston West Virginia 25304

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00423605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 29, 2012 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00423605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →