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Completed Phase 3 Interventional Results available

A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

ClinicalTrials.gov ID: NCT00371137

Public ClinicalTrials.gov record NCT00371137. 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 Sep 5, 2026, 10:10 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 Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® 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® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Study identification

NCT ID
NCT00371137
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
548 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
Jul 31, 2006
Primary completion
Aug 31, 2008
Completion
Nov 30, 2008
Last update posted
Dec 28, 2011

2006 – 2008

United States locations

U.S. sites
70
U.S. states
25
U.S. cities
63
Facility City State ZIP Site status
Pinnacle Research Group, LLC Anniston Alabama 36207
Rheumatology Associates of N. AL, PC Huntsville Alabama 35801
Xenoscience, Inc. dba 21st Century Neurology Phoenix Arizona 85004
Arizona Research Center Phoenix Arizona 85023
Advanced Clinical Research Institute Anaheim California 92801
Providence Clinical Research Burbank California 91505
Northern California Research Carmichael California 95608
Pasadena Rehabilitation Institute Pasadena California 91105
Arroyo Medical Group Pismo Beach California 93449
Sacramento Research Medical Group Sacramento California 95825
Apex Research Institute Santa Ana California 92705
Sansum Clinic Santa Barbara California 93110
Robert E. Harris, MD Medical Corporation Whittier California 90601
CRIA Research Fort Lauderdale Florida 33334
Clinical Physiology Associates Clinical Study Center Fort Meyers Florida 33916
Innovative Research Largo Florida 33770
Compass Research Orlando Florida 32806
Sunrise Medical Research Plantation Florida 33317
Coastal Medical Research, Inc Port Orange Florida 32127
Deerpath Physicians Group Gurnee Illinois 60031
Balanced health Research Center Peoria Illinois 61614
Welborn Clinic Evansville Indiana 47713
Investigative Clinical Research of Indiana, LLC Indianapolis Indiana 46254
Graves - Gilbert Clinic Bowling Green Kentucky 42101
Central Kentucky Research Associates, Inc. Lexington Kentucky 40509
Commonwealth Biomedical Reseach, LLC Madisonville Kentucky 42431
FutureCare Studies Springfield Massachusetts 01103
Clinical Pharmacology Study Group Worcester Massachusetts 01610
PCM Medical Services Lansing Michigan 48917
Clinvest Springfield Missouri 65807
Clayton Medical Associates St Louis Missouri 63117
St. John's Mercy Health System St Louis Missouri 63141
Quality Clinical Research, Inc. Omaha Nebraska 68114
CCR Trials Berlin New Jersey 08009
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
Great Lakes Medical Research Westfield New York 14787
Carolina Bone and Joint Charlotte North Carolina 28210
Carolinas Research Charlotte North Carolina 28226
Duke University Medical Center Durham North Carolina 27705
Wake Research Associates, LLC Raleigh North Carolina 27612
The Center for Clinical Research Winston-Salem North Carolina 27103
Radiant Research Columbus Ohio 43212
Signal Point Clinical Research Center, LLC Middletown Ohio 45042
Radiant Research Mogadore Ohio 44260
Clinical Research Source, Inc. Perrysburg Ohio 43551
Health Research Institute Oklahoma City Oklahoma 73109
Tulsa Clinical Research, LLC Tulsa Oklahoma 74104
PRO Research Eugene Oregon 97401
Medford Medical Clinic, LLP Medford Oregon 97504
Central Pennsylvania Clinical Research Mechanicsburg Pennsylvania 17055
Omega Medical Research Warwick Rhode Island 02886
Low Country Research Center Charleston South Carolina 29406
Radiant Research, Greer Greer South Carolina 29651
Clinsearch Chattanooga Tennessee 37421
Rheumatology Consultants, PLLC Knoxville Tennessee 37909
Walter M. Chase, MD Austin Texas 78705
Future Search Trials of Neurology Future Research Trials Austin Texas 78756
DFW Wellness Fort Worth Texas 76108
The Methodist Hospital Systems Houston Texas 77030
Houston Sleep Center Houston Texas 77063
Sun Research Institute San Antonio Texas 78205
Radiant Research San Antonio Northeast San Antonio Texas 78217
The University of Texas Health Science Center San Antonio Texas 78229
Fatigue Consultation Center Salt Lake City Utah 84102
Richard A. Neiman, MD, Inc. Kirkland Washington 98034
Pacific Rheumatolgy Associates, Inc. Renton Washington 98055
Charrleston 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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00371137, 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 Dec 28, 2011 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00371137 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →