A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat 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

NCT00423813

Run by

Jazz Pharmaceuticals

People needed

573

Starts

2006-12-01

Expected to finish

2009-06-01

Last updated by the study team

2012-01-24

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

• Capstone Clinical Trials, Inc. — Birmingham, Alabama, United States
• Drug Research and Analysis Corporation — Montgomery, Alabama, United States
• dba 21st Century Neurology — Phoenix, Arizona, United States
• Orange County Clinical Trials — Anaheim, California, United States
• Providence Clinical Research — Burbank, California, United States
• Med Investigations, Inc. — Fair Oaks, California, United States
• North Orange County Research Institute, Inc. — Fullerton, California, United States
• Nerve Pro Research — Irvine, California, United States
• Northridge Neurological Center — Northridge, California, United States
• Arroyo Medical Group — Pismo Beach, California, United States
• Northern California Research — Sacramento, California, United States
• Sacramento Research Medical Group — Sacramento, California, United States
• University of CT, Health Center — Farmington, Connecticut, United States
• Center for Musculoskeletal Pain Research — Gainesville, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Suncoast Internal Medicine Consultants — Largo, Florida, United States
• AppleMed Research — Miami, Florida, United States
• Compass Research — Orlando, Florida, United States
• Clinical Research Group of St. Petersburg, Inc. — St. Petersburg, Florida, United States
• Tampa Medical Group, P.A. — Tampa, Florida, United States
• Lake Rheumatology — Tavares, Florida, United States
• Center for Arthritis and Rheumatism — Vero Beach, Florida, United States
• Florida Medical Clinic, P.A., Clinical Research Division — Zephyrhills, Florida, United States
• Drug Studies America — Marietta, Georgia, United States
• East Alabama Arthritis Center — Auburn, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.