Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00423605
First received: January 16, 2007
Last updated: March 28, 2012
Last verified: March 2012

January 16, 2007
March 28, 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) ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00423605
06-010
No
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