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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Xyrem®
Placebo
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring FMS, Fibro, pain, Body pain, tenderness, joint pain, stiffness, muscular pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. Exclusion Criteria: Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms. Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Rheumatology Associates of N. AL, PC
  • Xenoscience, Inc. dba 21st Century Neurology
  • Arizona Research Center
  • Advanced Clinical Research Institute
  • Providence Clinical Research
  • Northern California Research
  • Pasadena Rehabilitation Institute
  • Arroyo Medical Group
  • Sacramento Research Medical Group
  • Apex Research Institute
  • Sansum Clinic
  • Robert E. Harris, MD Medical Corporation
  • Clinical Physiology Associates Clinical Study Center
  • CRIA Research
  • Innovative Research
  • Compass Research
  • Sunrise Medical Research
  • Coastal Medical Research, Inc
  • Deerpath Physicians Group
  • Balanced health Research Center
  • Welborn Clinic
  • Investigative Clinical Research of Indiana, LLC
  • Graves - Gilbert Clinic
  • Central Kentucky Research Associates, Inc.
  • Commonwealth Biomedical Reseach, LLC
  • FutureCare Studies
  • Clinical Pharmacology Study Group
  • PCM Medical Services
  • Clinvest
  • Clayton Medical Associates
  • St. John's Mercy Health System
  • Quality Clinical Research, Inc.
  • CCR Trials
  • School of Osteopathic Medicine
  • Anderson & Collins Clinical Research, Inc.
  • Upstate Clinical Research, LLC
  • AAIR Research Center
  • Great Lakes Medical Research
  • Carolina Bone and Joint
  • Carolinas Research
  • Duke University Medical Center
  • Wake Research Associates, LLC
  • The Center for Clinical Research
  • Radiant Research
  • Signal Point Clinical Research Center, LLC
  • Radiant Research
  • Clinical Research Source, Inc.
  • Health Research Institute
  • Tulsa Clinical Research, LLC
  • PRO Research
  • Medford Medical Clinic, LLP
  • Central Pennsylvania Clinical Research
  • Omega Medical Research
  • Low Country Research Center
  • Radiant Research, Greer
  • Clinsearch
  • Rheumatology Consultants, PLLC
  • Walter M. Chase, MD
  • Future Search Trials of Neurology Future Research Trials
  • DFW Wellness
  • The Methodist Hospital Systems
  • Houston Sleep Center
  • Sun Research Institute
  • Radiant Research San Antonio Northeast
  • The University of Texas Health Science Center
  • Fatigue Consultation Center
  • Richard A. Neiman, MD, Inc.
  • Pacific Rheumatolgy Associates, Inc.
  • Charrleston Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).
Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2006
Last Updated
December 21, 2011
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00371137
Brief Title
A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
Detailed Description
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
FMS, Fibro, pain, Body pain, tenderness, joint pain, stiffness, muscular pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Xyrem®
Intervention Description
two doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Solution
Primary Outcome Measure Information:
Title
Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).
Description
Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.
Time Frame
Baseline to Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. Exclusion Criteria: Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms. Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I. Jon Russell, PhD, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Rheumatology Associates of N. AL, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Xenoscience, Inc. dba 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Northern California Research
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Pasadena Rehabilitation Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Arroyo Medical Group
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Sacramento Research Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
Robert E. Harris, MD Medical Corporation
City
Whittier
State/Province
California
ZIP/Postal Code
90601
Country
United States
Facility Name
Clinical Physiology Associates Clinical Study Center
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
CRIA Research
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Innovative Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sunrise Medical Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Coastal Medical Research, Inc
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Deerpath Physicians Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Balanced health Research Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Graves - Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Commonwealth Biomedical Reseach, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
FutureCare Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
PCM Medical Services
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48917
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Clayton Medical Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
St. John's Mercy Health System
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
CCR Trials
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
School of Osteopathic Medicine
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Anderson & Collins Clinical Research, Inc.
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Great Lakes Medical Research
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Carolina Bone and Joint
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Carolinas Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Radiant Research
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Clinical Research Source, Inc.
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
PRO Research
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Medford Medical Clinic, LLP
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Central Pennsylvania Clinical Research
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Low Country Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Radiant Research, Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Clinsearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Rheumatology Consultants, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Walter M. Chase, MD
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Future Search Trials of Neurology Future Research Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
DFW Wellness
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76108
Country
United States
Facility Name
The Methodist Hospital Systems
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Sleep Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Radiant Research San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
The University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fatigue Consultation Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Richard A. Neiman, MD, Inc.
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Pacific Rheumatolgy Associates, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Charrleston Internal Medicine
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21397402
Citation
Russell JI, Holman AJ, Swick TJ, Alvarez-Horine S, Wang GY, Guinta D; Sodium Oxybate 06-008 FM Study Group. Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study. Pain. 2011 May;152(5):1007-1017. doi: 10.1016/j.pain.2010.12.022. Epub 2011 Mar 11.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
19116896
Citation
Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2009 Jan;60(1):299-309. doi: 10.1002/art.24142.
Results Reference
result
Citation
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.
Results Reference
result
Citation
Spaeth M, Russell IJ, Perrot S, Choy E, Benson B, Wang YG, Lai C. The Effects of Sodium Oxybate on Multiple Symptoms of Fibromyalgia: Results From Two Phase 3, Randomized, Double-Blind, Controlled Trials. In: Myopain 2010 Abstracts; October 3-7, 2010; Toledo, Spain. Abstract 39.
Results Reference
result

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

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