A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00423813|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : January 10, 2012
Last Update Posted : January 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: placebo Drug: Xyrem®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||573 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||June 2009|
|Placebo Comparator: 1||
- Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF). [ Time Frame: Baseline to Week 14 ]Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423813