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
  Purpose

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.


Condition Intervention Phase
Fibromyalgia
Drug: Xyrem®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects Reporting Adverse Events [ Time Frame: Treatment Period (38 weeks) ] [ Designated as safety issue: Yes ]
    Number of subjects reporting adverse events.


Enrollment: 560
Study Start Date: December 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Xyrem®
flexible dosing

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423605

  Show 91 Study Locations
Sponsors and Collaborators
Jazz Pharmaceuticals
  More Information

Publications:
Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00423605     History of Changes
Other Study ID Numbers: 06-010
Study First Received: January 16, 2007
Results First Received: September 12, 2011
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jazz Pharmaceuticals:
FMS
Fibro
Pain
Body Pain
Tenderness
Joint pain
Stiffness
Muscular Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014