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Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With 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: NCT00423605
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : October 20, 2011
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):

January 16, 2007
January 18, 2007
September 12, 2011
October 20, 2011
March 30, 2012
December 2006
January 2010   (Final data collection date for primary outcome measure)
Number of Subjects Reporting Adverse Events [ Time Frame: Treatment Period (38 weeks) ]
Number of subjects reporting adverse events.
  • Pain severity accessed VAS
  • Fibromyalgia Impact Questionnaire
  • Patient Global Impression of Change
Complete list of historical versions of study NCT00423605 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fibromyalgia
Drug: Xyrem®
flexible dosing
Experimental: 1
Intervention: Drug: Xyrem®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
560
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
  • Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.

Exclusion Criteria:

  • Subject terminated early from either study 06-009 or 06-008.
  • Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
  • Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
 
 
NCT00423605
06-010
No
Not Provided
Not Provided
Jazz Pharmaceuticals
Jazz Pharmaceuticals
Not Provided
Not Provided
Jazz Pharmaceuticals
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP