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A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo
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, stiffness, muscular pain, joint 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

  • East Alabama Arthritis Center
  • Capstone Clinical Trials, Inc.
  • Drug Research and Analysis Corporation
  • dba 21st Century Neurology
  • Orange County Clinical Trials
  • Providence Clinical Research
  • Med Investigations, Inc.
  • North Orange County Research Institute, Inc.
  • Nerve Pro Research
  • Northridge Neurological Center
  • Arroyo Medical Group
  • Northern California Research
  • Sacramento Research Medical Group
  • University of CT, Health Center
  • Center for Musculoskeletal Pain Research
  • Florida Institute of Medical Research
  • Suncoast Internal Medicine Consultants
  • AppleMed Research
  • Compass Research
  • Clinical Research Group of St. Petersburg, Inc.
  • Tampa Medical Group, P.A.
  • Lake Rheumatology
  • Center for Arthritis and Rheumatism
  • Florida Medical Clinic, P.A., Clinical Research Division
  • Drug Studies America
  • Coeur d'Alene Arthritis Clinic
  • Fibromyalgia Treatment Centers of America
  • Investigative Clinical Research of Indiana, LLC
  • Cotton-O'neil Clinical Research center
  • Center for Arthritis and Osteoporosis
  • Central Kentucky Research Associates,Inc.
  • Bluegrass Internal Medicine
  • Louisiana Sleep Foundation
  • Capital Clinical Research Associates
  • Professional Clinical Research at Cyrstal Lake Health Center
  • Quest Research Institute
  • Professional Clinical Research
  • Professional Clinical Research at Crystal Lake Health Center
  • Arthritis Associates
  • Medex Healthcare Research, Inc
  • St. John's Mercy Health System
  • Quality Clinical Research, Inc.
  • Comprehensive Clinical Research
  • Alan Lichtbroun, MD
  • Albuquerque Neuroscience, Inc.
  • North Shore University Hospital, North Shore Pain Services
  • Great Lakes Medical Research
  • Appalachian Regional Medical Associates
  • Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU
  • The Center for Clinical Research
  • Hightop Medical Research Center
  • Health Research Associates, LLC (HRA)
  • Ohio State U, Immunology/Rheumatology William Davis Medical Research Center
  • Cleveland Neuro-Sleep Research Institute Inc.
  • Summit Research Network (Oregon) Inc.
  • Oregon Health Sciences University School of Medicine
  • Tri State Medical Group, Inc.
  • Altoona Center for Clinical Research
  • Founders Research
  • Southern Orthopaedic Sports Medicine
  • Neurology Future Research Trials
  • DFW Wellness
  • The Methodist Hospital System
  • Houston Sleep Center
  • R/D Clinical Research, Inc.
  • Sun Research Institute
  • University of Texas Health Science Center
  • Arthritis & Osteoporosis Center of South Texas
  • Clinical Health Research, LLC
  • Arthritis and Osteoporosis Clinic, Research Center of Central Texas
  • Alben Goldstein, MD, FACP
  • Rhumatologie
  • CHU de Grenoble-hopital Sud
  • Hopital Claude Huriez Service de medecine Interne
  • Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord
  • Hopital Pasteue - Pavillon O
  • Hopital Hotel Dieu service de medecine interne
  • CHU Hopital de Rangueil
  • Schlosspark-Klinik
  • Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie
  • Praxis Dr. Wiedeking
  • Praxis fur Innere Medizin und Rheumatologie
  • Gemeinschaftspraxis Schmerzzentrum
  • Rheumazentrum am Krankenhaus Bad Doberan
  • Intensivmedizin der Uniklinik Koln
  • Praxisklinik Dr. Weiss
  • Praxis Dr. Sohn
  • Azienda Ospedaliera Luigi Sacco
  • Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
  • Amphia Ziekenhuis
  • Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis
  • Wojewodzki Szpital Zespolony
  • Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny
  • Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny
  • w Szczecinie
  • NZOZ Nasz Lekarz
  • Instytut Reumatologii
  • Hospital Santa Creu i Sant Pau
  • Hospital Universitari Vall d'Hebron
  • Instituto Ferran de Reumatologia
  • Hospital Universitario de Guadalajara
  • Hospital Universitario de Canarias
  • Hospital Universitario de Gran Canaria Dr. Negrin
  • Hospital Civil de malaga
  • Hospital Central de Asturias
  • Hospital Clinico Universitario de Santiago
  • Barnsley District General Hospital, Rheumatology Department
  • Royal National Hospital for Rheumatic Diseases NHS
  • Lever Chambers Centre for Health
  • King's College London
  • 4 West Kennedy Clinical Trial unit
  • King College London
  • Freeman Hospital
  • Freeman Hospital
  • Philip Arnold Unit
  • Poole General Hospital

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
January 16, 2007
Last Updated
January 20, 2012
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00423813
Brief Title
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (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-two (22) 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 a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) 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, stiffness, muscular pain, joint pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
573 (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)
placebo
Intervention Description
Oral Solution
Intervention Type
Drug
Intervention Name(s)
Xyrem®
Intervention Description
two doses
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.
Facility Information:
Facility Name
East Alabama Arthritis Center
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
Facility Name
Capstone Clinical Trials, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Drug Research and Analysis Corporation
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
dba 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Orange County Clinical Trials
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
Med Investigations, Inc.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
North Orange County Research Institute, Inc.
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Nerve Pro Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Northridge Neurological Center
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Arroyo Medical Group
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Sacramento Research Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
University of CT, Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1310
Country
United States
Facility Name
Center for Musculoskeletal Pain Research
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Suncoast Internal Medicine Consultants
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
AppleMed Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Clinical Research Group of St. Petersburg, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Lake Rheumatology
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Center for Arthritis and Rheumatism
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32962
Country
United States
Facility Name
Florida Medical Clinic, P.A., Clinical Research Division
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Coeur d'Alene Arthritis Clinic
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Fibromyalgia Treatment Centers of America
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
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
Cotton-O'neil Clinical Research center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Center for Arthritis and Osteoporosis
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Central Kentucky Research Associates,Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Bluegrass Internal Medicine
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Louisiana Sleep Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Capital Clinical Research Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Professional Clinical Research at Cyrstal Lake Health Center
City
Benzonia
State/Province
Michigan
ZIP/Postal Code
49616
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Professional Clinical Research
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Professional Clinical Research at Crystal Lake Health Center
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49643
Country
United States
Facility Name
Arthritis Associates
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
Medex Healthcare Research, Inc
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
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Alan Lichtbroun, MD
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
North Shore University Hospital, North Shore Pain Services
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
Country
United States
Facility Name
Great Lakes Medical Research
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Appalachian Regional Medical Associates
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607-0000
Country
United States
Facility Name
Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
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
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Health Research Associates, LLC (HRA)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Ohio State U, Immunology/Rheumatology William Davis Medical Research Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cleveland Neuro-Sleep Research Institute Inc.
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Summit Research Network (Oregon) Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Health Sciences University School of Medicine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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
Founders Research
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Southern Orthopaedic Sports Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
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 System
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
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
78215
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arthritis & Osteoporosis Center of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Clinical Health Research, LLC
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Arthritis and Osteoporosis Clinic, Research Center of Central Texas
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Alben Goldstein, MD, FACP
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22204
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 traitment de la douleur CHU Nord
City
Nantes Cedex 2
Country
France
Facility Name
Hopital Pasteue - Pavillon O
City
Nice Cedex 1
Country
France
Facility Name
Hopital Hotel Dieu service de medecine interne
City
Paris Cedex 04
Country
France
Facility Name
CHU Hopital de Rangueil
City
Toulouse Cedex 9
Country
France
Facility Name
Schlosspark-Klinik
City
Berlin
Country
Germany
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
Rheumazentrum am Krankenhaus Bad Doberan
City
Hohenfelde - Bad Doberan
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 Luigi Sacco
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
City
Pisa
Country
Italy
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis
City
Enschede
Country
Netherlands
Facility Name
Wojewodzki Szpital Zespolony
City
Elblag
Country
Poland
Facility Name
Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny
City
Katowice
Country
Poland
Facility Name
Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny
City
Poznan
Country
Poland
Facility Name
w Szczecinie
City
Szczecinie
Country
Poland
Facility Name
NZOZ Nasz Lekarz
City
Torun
Country
Poland
Facility Name
Instytut Reumatologii
City
Warszawa
Country
Poland
Facility Name
Hospital Santa Creu i Sant 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 Universitario de Canarias
City
La Laguna
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
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
Barnsley District General Hospital, Rheumatology Department
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Royal National Hospital for Rheumatic Diseases NHS
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
Lever Chambers Centre for Health
City
Bolton
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 9RJ
Country
United Kingdom
Facility Name
4 West Kennedy Clinical Trial unit
City
London
Country
United Kingdom
Facility Name
King College London
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon tyne
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Philip Arnold Unit
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Poole General Hospital
City
Poole
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Bennett RM, Benson B, Choy EH, Hackshaw KV, Alvarez-Horine S, Wang, YG, Spaeth M. Effects of Sodium Oxybate on Pain, Function, and PGIC in Fibromyalgia: Results From an International, 14-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. [AAPM abstract 186]. Pain Med. 2010;11(2):317.
Results Reference
result
Citation
Swick TJ, Spaeth M, Choy EH, Alvarez-Horine S, Wang YG, Benson B, Bennett R. Sodium Oxybate Reduces Pain and Improves Function and PGIC in Fibromyalgia: Results From an International, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial [AAN abstract P03.293]. Neurology. 2010;74(suppl 2):A280.
Results Reference
result
Citation
Bennett RM, Rosenthal N, Lai C, Benson B, Wang YG, Alegre C, Perrot S.. Functionality and Quality of Life Are Improved in Fibromyalgia Patients Treated With Sodium Oxybate: Results From a Phase 3 International Trial. In: American Psychiatric Association New Research Abstracts to the 2010 Annual Meeting; May 22-26, 2010; New Orleans, LA. Abstract NR7-49.
Results Reference
result
Citation
Swick TJ, Curtis C, Benson B, Lai C, Wang YG, Rothman J, Sarzi-Puttini P. Fibromyalgia Patients Have Impaired Sleep and Daytime Functioning at Baseline: Data From an International Phase 3 Trial of Sodium Oxybate [APSS abstract 0882]. Sleep. 2010;33(suppl):A295.
Results Reference
result
Citation
Swick TJ, Lai C, Benson B, Wang YG, Sarzi-Puttini P. Fibromyalgia Pain, Fatigue, and Sleep Improve With Sodium Oxybate Treatment: A 14-Week Randomized, Double-Blind, Placebo-Controlled International Trial [APSS abstract 0883]. Sleep. 2010;33(suppl):A295.
Results Reference
result
Citation
Choy E, Alegre C, Sarzi-Puttini P, van Seventer R, Wang YG, Guinta D, Lai C, Bennett R and the Oxybate in Fibromyalgia 06-009 Study Group. The Effects of Sodium Oxybate on Sleep Disturbance, Fatigue, and Functioning in Fibromyalgia: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled International Trial [FRI10411]. Ann Rheum Dis. 2010;69(suppl 3):449.
Results Reference
result
Citation
Spaeth M, Perrot S, Samborski W, Bazzichi L, van de Laar M, Guinta D, Wang YG, Lai C, Bennett R and Sodium Oxybate in Fibromyalgia 06-009 Study Group. Sodium Oxybate Treatment Improves Pain, Function, and Patient Global Impression of Change (PGIC) in Fibromyalgia Patients: Results From an International, Randomized, Double-Blind, Placebo-Controlled Trial. Ann Rheum Dis. 2010;69(suppl 3):449
Results Reference
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A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

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