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

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT00371137

Run by

Jazz Pharmaceuticals

People needed

548

Starts

2006-08-01

Expected to finish

2008-12-01

Last updated by the study team

2011-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.

You may not qualify if…

• Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
• Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.

Where it is running

• Rheumatology Associates of N. AL, PC — Huntsville, Alabama, United States
• Xenoscience, Inc. dba 21st Century Neurology — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Providence Clinical Research — Burbank, California, United States
• Northern California Research — Carmichael, California, United States
• Pasadena Rehabilitation Institute — Pasadena, California, United States
• Arroyo Medical Group — Pismo Beach, California, United States
• Sacramento Research Medical Group — Sacramento, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Robert E. Harris, MD Medical Corporation — Whittier, California, United States
• CRIA Research — Fort Lauderdale, Florida, United States
• Clinical Physiology Associates Clinical Study Center — Fort Meyers, Florida, United States
• Innovative Research — Largo, Florida, United States
• Compass Research — Orlando, Florida, United States
• Sunrise Medical Research — Plantation, Florida, United States
• Coastal Medical Research, Inc — Port Orange, Florida, United States
• Deerpath Physicians Group — Gurnee, Illinois, United States
• Balanced health Research Center — Peoria, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• Investigative Clinical Research of Indiana, LLC — Indianapolis, Indiana, United States
• Graves - Gilbert Clinic — Bowling Green, Kentucky, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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