NCT00423813

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

A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 573 (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® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Detailed description

The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	placebo	Oral Solution
DRUG	Xyrem®	two doses

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2007-01-18
• Last updated: 2012-01-24
• Results posted: 2012-01-10

Locations

116 sites across 8 countries: United States, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom