Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Completed · Phase 3

Conditions studied: Fibromyalgia

In brief

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

Key facts

Study ID

NCT00423605

Run by

Jazz Pharmaceuticals

People needed

560

Starts

2006-12-01

Expected to finish

2010-01-01

Last updated by the study team

2012-03-30

Who can join

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

You may qualify if…

• Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
• Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.

You may not qualify if…

• Subject terminated early from either study 06-009 or 06-008.
• Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
• Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.

Where it is running

• Suncoast Internal Medicine Consultants — Auburn, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Orange County Clinical Trials — Anaheim, California, United States
• Northern California Research — Carmichael, California, United States
• Med Investigations Inc. — Fair Oaks, California, United States
• Nerve Pro Research — Irvine, California, United States
• Arroyo Medical Group, Inc. — Pismo Beach, California, United States
• AppleMed Research — Miami, Florida, United States
• Compass Research — Orlando, Florida, United States
• Sunrise Medical Research — Plantation, Florida, United States
• Clinical Research Group of St. Petersburg, Inc — St. Petersburg, Florida, United States
• Tampa Medical Group, P.A. — Tampa, Florida, United States
• Center for Arthiritis and Rheumatism — Vero Beach, Florida, United States
• Florida Medical Clinic, P.A. — Zephyhills, Florida, United States
• Drug Studies America — Marietta, Georgia, United States
• Coeur d' Alene Arthritis Clinic — Coeur d'Alene, Idaho, United States
• Fibromyalgia Treatment Centers of America — Chicago, Illinois, United States
• Deerpath Physcians Group — Gurnee, Illinois, United States
• Balanced Health Research Center — Peoria, Illinois, United States
• Graves - Gilbert Clinic — Bowling Green, Kentucky, United States
• Center for Arthiritis & Osteoporosis — Elizabethtown, Kentucky, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• Commonwealth Biomedical Research, LLC — Madisonville, Kentucky, United States
• Pinnacle Research Group, LLC — Anniston, 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.