NCT00371137

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 548 (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-one (21) 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 one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.

Conditions

• Fibromyalgia

Interventions

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

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2006-09-01
• Last updated: 2011-12-29
• Results posted: 2011-11-30

Locations

70 sites across 1 country: United States