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Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xyrem®
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:

  • 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.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Suncoast Internal Medicine Consultants
  • Arizona Research Center
  • Advanced Clinical Research Institute
  • Orange County Clinical Trials
  • Northern California Research
  • Med Investigations Inc.
  • Nerve Pro Research
  • Arroyo Medical Group, Inc.
  • AppleMed Research
  • Compass Research
  • Sunrise Medical Research
  • Clinical Research Group of St. Petersburg, Inc
  • Tampa Medical Group, P.A.
  • Center for Arthiritis and Rheumatism
  • Florida Medical Clinic, P.A.
  • Drug Studies America
  • Coeur d' Alene Arthritis Clinic
  • Fibromyalgia Treatment Centers of America
  • Deerpath Physcians Group
  • Balanced Health Research Center
  • Graves - Gilbert Clinic
  • Center for Arthiritis & Osteoporosis
  • Central Kentucky Research Associates, Inc.
  • Commonwealth Biomedical Research, LLC
  • Louisiana Sleep Foundation
  • Capital Clinical Rsearch Asociates
  • FutureCare Studies
  • Clinical Pharmacology Study Group
  • Professional Clinical Research, Inc. at Crystal Lake Health Center
  • Professional Clinical Research
  • Professional Clinical Research at Crystal Lake Health Center
  • PCM Medical Services
  • Clinvest
  • School of Osteopathic Medicine
  • Anderson & Collins Clinical Research, Inc.
  • Upstate Clinical Research, LLC
  • AAIR Research Center
  • North Shore University Hospital
  • Appalachian Regional Medical Associates
  • Carolina Bone and Joint
  • Duke University Medical Center
  • Wake Research Associates, LLC
  • The Center for Clinical Research
  • Hill Top Physicians Inc./Hightop Medical Research Center
  • Radiant Research
  • Tulsa Clinical Research, LLC
  • PRO Research
  • School of Nursing
  • Tri State Medical Group, Inc.
  • Altoona Center for Clinical Research
  • Central Pennsylvania Clinical Research
  • Omega Medical Research
  • Low Country Research Country
  • Southern Orthopaedic Sports Medicine
  • Radiant Research, Greer
  • Rheumatology Consultants, PLLC
  • Walter F. Chase, MD PA
  • R/D Clinical Research, Inc.
  • Sun Research Institute
  • Radiant Research San Antonio Northeast
  • The University of Texas Health Science
  • Fatigue Consultation Center
  • Evergreen Hospital Medical Center
  • Pacific Rheumatology Associates, Inc.
  • Charleston Internal Medicine
  • Rhumatologie
  • CHU de Grenoble-Hopital Sud
  • Hopital Claude Huriez Service de medecine interne
  • Centre Catherine de Sienne unite d evaluation et de traitement de la douleur
  • Hopital Hotel Dieu service de medicine interne
  • CHU Hopital de Rangueil
  • Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie
  • Praxis Dr. Wiedeking
  • Praxis fur Innere Medizin und Rheumatologie
  • Gemeinschaftspraxis Schmerzzentrum
  • Intensivmedizin der Uniklinik Koln
  • Praxisklinik Dr. Weiss
  • Praxis Dr. Sohn
  • Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
  • Amphia Ziekenhuis
  • Hospital Santa Creu i Snt Pau
  • Hospital Universitari Vall d'Hebron
  • Instituto Ferran de Reumatologia
  • Hospital Universitario de Guadalajara
  • Hospital Civil de Malaga
  • Hospital Central de Asturias
  • Hospital Clinico Universitario de Santiago
  • Lever Chambers Centre for Health
  • Kings College London
  • Freeman Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Adverse Events
Number of subjects reporting adverse events.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2007
Last Updated
March 28, 2012
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00423605
Brief Title
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Official Title
A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (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® 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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Xyrem®
Intervention Description
flexible dosing
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Adverse Events
Description
Number of subjects reporting adverse events.
Time Frame
Treatment Period (38 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Suncoast Internal Medicine Consultants
City
Auburn
State/Province
Alabama
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
Orange County Clinical Trials
City
Anaheim
State/Province
California
Country
United States
Facility Name
Northern California Research
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Med Investigations Inc.
City
Fair Oaks
State/Province
California
Country
United States
Facility Name
Nerve Pro Research
City
Irvine
State/Province
California
Country
United States
Facility Name
Arroyo Medical Group, Inc.
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
AppleMed Research
City
Miami
State/Province
Florida
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
Clinical Research Group of St. Petersburg, Inc
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Center for Arthiritis and Rheumatism
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyhills
State/Province
Florida
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Coeur d' Alene Arthritis Clinic
City
Coeur d' Alene
State/Province
Idaho
Country
United States
Facility Name
Fibromyalgia Treatment Centers of America
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Deerpath Physcians 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
Graves - Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Center for Arthiritis & Osteoporosis
City
Elizabethtown
State/Province
Kentucky
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 Research, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Louisiana Sleep Foundation
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Capital Clinical Rsearch Asociates
City
Rockville
State/Province
Maryland
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
Professional Clinical Research, Inc. at Crystal Lake Health Center
City
Benzonia
State/Province
Michigan
Country
United States
Facility Name
Professional Clinical Research
City
Cadillac
State/Province
Michigan
Country
United States
Facility Name
Professional Clinical Research at Crystal Lake Health Center
City
Interlocken
State/Province
Michigan
ZIP/Postal Code
49643
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
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
North Shore University Hospital
City
Valley Stream
State/Province
New York
Country
United States
Facility Name
Appalachian Regional Medical Associates
City
Boone
State/Province
North Carolina
Country
United States
Facility Name
Carolina Bone and Joint
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27103
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
Hill Top Physicians Inc./Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Radiant Research
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
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
School of Nursing
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Tri State Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
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 Country
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Southern Orthopaedic Sports Medicine
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Radiant Research, Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Rheumatology Consultants, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Walter F. Chase, MD PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
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
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
Evergreen Hospital Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Pacific Rheumatology Associates, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Charleston Internal Medicine
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Rhumatologie
City
Amiens Cedex 1
Country
France
Facility Name
CHU de Grenoble-Hopital Sud
City
Echirolles Cedex
Country
France
Facility Name
Hopital Claude Huriez Service de medecine interne
City
Lille Cedex
Country
France
Facility Name
Centre Catherine de Sienne unite d evaluation et de traitement de la douleur
City
Nantes cedex 2
Country
France
Facility Name
Hopital Hotel Dieu service de medicine interne
City
Paris cedex 04
Country
France
Facility Name
CHU Hopital de Rangueil
City
Toulouse Cedex 9
Country
France
Facility Name
Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie
City
Boblingen
Country
Germany
Facility Name
Praxis Dr. Wiedeking
City
Essen
Country
Germany
Facility Name
Praxis fur Innere Medizin und Rheumatologie
City
Grafelfing
Country
Germany
Facility Name
Gemeinschaftspraxis Schmerzzentrum
City
Hamburg
Country
Germany
Facility Name
Intensivmedizin der Uniklinik Koln
City
Koln
Country
Germany
Facility Name
Praxisklinik Dr. Weiss
City
Mannheim
Country
Germany
Facility Name
Praxis Dr. Sohn
City
Schwalmtal
Country
Germany
Facility Name
Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara
City
Pisa
Country
Italy
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Hospital Santa Creu i Snt Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Instituto Ferran de Reumatologia
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Guadalajara
City
Guadalajara
Country
Spain
Facility Name
Hospital Civil de Malaga
City
Malaga
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Lever Chambers Centre for Health
City
Bolton
Country
United Kingdom
Facility Name
Kings College London
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
24286114
Citation
Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

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