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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 Oct 27, 2026, 6:59 PM 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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

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

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
Dec 2006 (Type not available)
Primary completion
Jan 2010 (Actual)
Completion
Jan 2010 (Actual)
Last update posted
Mar 30, 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 30, 2012 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00423605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →