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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
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fibromyalgia
Intervention: Drug: Xyrem®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Xyrem 4.5 g to 9.0 g Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses

Participant Flow:   Overall Study
    Xyrem 4.5 g to 9.0 g  
STARTED     560  
COMPLETED     319  
NOT COMPLETED     241  
Adverse Event                 129  
Withdrawal by Subject                 36  
Lost to Follow-up                 15  
Lack of Efficacy                 38  
Sponsor Decision                 3  
Physician Decision                 8  
Protocol Violation                 7  
Not one of the pre-specified options                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Xyrem 4.5 g to 9.0 g Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses

Baseline Measures
    Xyrem 4.5 g to 9.0 g  
Number of Participants  
[units: participants]
  560  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 10.84  
Age, Customized  
[units: participants]
 
18 - 39 years     144  
40 - 49 years     181  
50 - 64 years     212  
>=65 years     23  
Gender  
[units: participants]
 
Female     510  
Male     50  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     5  
Asian     6  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     34  
White     512  
More than one race     2  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
France     13  
United States     465  
Spain     35  
Netherlands     2  
Germany     34  
Italy     3  
United Kingdom     8  



  Outcome Measures

1.  Primary:   Number of Subjects Reporting Adverse Events   [ Time Frame: Treatment Period (38 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Grace Wang, MD, Director Clinical Development & Medical Monitor
Organization: Jazz Pharmaceuticals, Inc.
phone: 650-496-3777


Publications of Results:
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.

Publications automatically indexed to this study:

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