A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00371137
First received: August 30, 2006
Last updated: December 21, 2011
Last verified: December 2011
Results First Received: September 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: Xyrem®
Drug: Placebo

  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
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Reporting Groups
  Description
Placebo Placebo taken as two equally divided nightly doses
Xyrem 4.5g Xyrem 4.5g taken as two equally divided nightly doses
Xyrem 6.0g Xyrem 6.0g taken as two equally divided nightly doses

Participant Flow:   Overall Study
    Placebo     Xyrem 4.5g     Xyrem 6.0g  
STARTED     183     182     183  
Treated     183     182     182  
COMPLETED     111     119     104  
NOT COMPLETED     72     63     79  
Adverse Event                 20                 35                 42  
Withdrawal by Subject                 11                 10                 15  
Lost to Follow-up                 6                 3                 5  
Lack of Efficacy                 30                 12                 13  
Sponsor Decision                 2                 1                 2  
Physician Decision                 1                 1                 1  
Protocol Violation                 2                 1                 1  



  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
Placebo Placebo taken as two equally divided nightly doses
Xyrem 4.5g Xyrem 4.5g taken as two equally divided nightly doses
Xyrem 6.0g Xyrem 6.0g taken as two equally divided nightly doses
Total Total of all reporting groups

Baseline Measures
    Placebo     Xyrem 4.5g     Xyrem 6.0g     Total  
Number of Participants  
[units: participants]
  183     182     183     548  
Age  
[units: years]
Mean ± Standard Deviation
  46.5  ± 11.43     47.0  ± 11.76     47.5  ± 10.61     47.0  ± 11.26  
Age, Customized  
[units: participants]
       
18 - 39 years     40     57     40     137  
40 - 49 years     70     47     57     174  
50 - 64 years     64     69     78     211  
>=65 years     9     9     8     26  
Gender  
[units: participants]
       
Female     167     166     167     500  
Male     16     16     16     48  
Race (NIH/OMB)  
[units: Participants]
       
American Indian or Alaska Native     2     2     2     6  
Asian     3     2     2     7  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     8     13     12     33  
White     167     164     167     498  
More than one race     3     0     0     3  
Unknown or Not Reported     0     1     0     1  
Region of Enrollment  
[units: participants]
       
United States     183     182     183     548  



  Outcome Measures

1.  Primary:   Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).   [ Time Frame: Baseline to Week 14 ]


  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, Medical Monitor & Director of Clinical Development
Organization: Jazz Pharmaceuticals, Inc.
phone: 650-496-3777


Publications of Results:
Swick TJ, Alvarez-Horine S, Zheng Y, Rothman J, Inhaber N, Holman AJ, Smith TR, Russell IJ. Sodium Oxybate Improves Pain, Fatigue, and Sleep in Fibromyalgia: Results from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial. [APSS abstract 0984]. Sleep 2009;32(suppl):A321.
Swick TJ, Alvarez-Horine S, Zheng Y, Guinta D, Inhaber N, Holman AJ, Smith TR, Russell IJ. Impaired Sleep and Daytime Functioning at Baseline in Subjects with Fibromyalgia from a 14-Week Randomized, Double-Blind, Placebo-Controlled Trial of Sodium Oxybate. [APSS abstract 1013]. Sleep 2009;32(suppl):A330.
Mease PJ, Swick TJ, Alvarez-Horine S, Inhaber N, Guinta DR, Holman AJ, and Russell IJ. Sodium Oxybate Improves Fatigue, Sleep Disturbance, and PGIC in Fibromyalgia-Results form a Phase 3, 14-Week, Controlled Trial. Arthritis & Rheum 2009;60(10):S529.
Russell IJ, Alvarez-Horine S, Zheng Y, Guinta DR, Holman AJ and Swick TJ. Effect of Sodium Oxybate on Pain, PGIC, & Composite Scores in Fibromyalgia-Results from a Phase 3 Controlled Trial. Arthritis & Rheum 2009;60(10):S528.
Swick TJ, Rosenfeld V, Alvarez-Horine S, Guinta D, Wang YG, Russell IJ. Improvement in Multiple Symptoms of Fibromyalgia With Sodium Oxybate Treatment: Results From a US Phase 3 Randomized, Controlled Trial [AAN abstract P03.292]. Neurology. 2010;74(suppl 2):A279.
Jones KD, Bennett RM, Alvarez-Horine S, Wang YG, Guinta D, Russell IJ. Sodium Oxybate Improves Function and Quality of Life in Fibromyalgia—Results From a Phase 3, Randomized, Controlled Trial [APS abstract 262]. J Pain. 2010;11(suppl 1):S41.
Silverman S, Holman AJ, Benson B, Alvarez-Horine S, Wang YG, Sarzi-Puttini. Sodium Oxybate Improves Sleep and Fatigue in Patients With Fibromyalgia: Pooled Analysis From 2 Pivotal Clinical Trials [ACR/ARHP abstract 2337]. Arthritis Rheum. 2010;62(suppl 10):815.


Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00371137     History of Changes
Other Study ID Numbers: 06-008
Study First Received: August 30, 2006
Results First Received: September 8, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration