NCT00423605

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

A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Xyrem®	flexible dosing

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-01-18
• Last updated: 2012-03-30
• Results posted: 2011-10-20

Locations

91 sites across 7 countries: United States, France, Germany, Italy, Netherlands, Spain, United Kingdom