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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 16, 2007
Last Updated Date	March 28, 2012
Start Date ^ICMJE	December 2006
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 24, 2011)	Number of Subjects Reporting Adverse Events [ Time Frame: Treatment Period (38 weeks) ] [ Designated as safety issue: Yes ] Number of subjects reporting adverse events.
Original Primary Outcome Measures ^ICMJE (submitted: January 16, 2007)	Pain severity accessed VAS Fibromyalgia Impact Questionnaire Patient Global Impression of Change
Change History	Complete list of historical versions of study NCT00423605 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Official Title ^ICMJE	A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Brief Summary	The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Fibromyalgia
Intervention ^ICMJE	Drug: Xyrem® flexible dosing
Study Arm (s)	Experimental: 1 Intervention: Drug: Xyrem®
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	560
Completion Date	January 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, France, Germany, Italy, Netherlands, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00423605
Other Study ID Numbers ^ICMJE	06-010
Has Data Monitoring Committee	No
Responsible Party	Jazz Pharmaceuticals
Study Sponsor ^ICMJE	Jazz Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Jazz Pharmaceuticals
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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