At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 573 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
In Brief
A Phase 3 clinical trial evaluating placebo and Xyrem® for Fibromyalgia. Completed, enrolled 573 participants across 116 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesFrance, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedJan 2007
Primary CompletionApr 2009
Study CompletionJun 2009
TodayJul 2026
First PostedJan 18, 2007
Enrollment StartDec 1, 2006
Primary CompletionApr 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.5 years ago
Interventions
placebodrug
Oral Solution
Xyrem®drug
two doses