Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
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 Oct 21, 2026, 7:08 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 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
Aug 2006 (Type not available)
Primary completion
Sep 2008 (Actual)
Completion
Dec 2008 (Actual)
Last update posted
Dec 29, 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 29, 2011 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00371137 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →