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FibromyalgiaPhase 3NCT00423813

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

A Phase 3 study testing Xyrem® in people with Fibromyalgia, run by Jazz Pharmaceuticals at 116 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibromyalgia
What is being tested?
Xyrem®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
573 participants
Where
116 sitesin 8 countries
Study dates
Dec 2006to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.

Who cannot join

  • 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.

Trial locations and contacts

116 sites in 8 countries.

116 sites in 8 countries

United States71 sites

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • Orange County Clinical Trials

    Anaheim, California, 92801

  • Alben Goldstein, MD, FACP

    Arlington, Virginia, 22204

  • East Alabama Arthritis Center

    Auburn, Alabama, 36830

  • Neurology Future Research Trials

    Austin, Texas, 78756

  • Louisiana Sleep Foundation

    Baton Rouge, Louisiana, 70809

  • Tri State Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Professional Clinical Research at Cyrstal Lake Health Center

    Benzonia, Michigan, 49616

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Quest Research Institute

    Bingham Farms, Michigan, 48025

  • Capstone Clinical Trials, Inc.

    Birmingham, Alabama, 35209

  • Appalachian Regional Medical Associates

    Boone, North Carolina, 28607-0000

  • Providence Clinical Research

    Burbank, California, 91505

  • Professional Clinical Research

    Cadillac, Michigan, 49601

  • Fibromyalgia Treatment Centers of America

    Chicago, Illinois, 60641

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • Health Research Associates, LLC (HRA)

    Cleveland, Ohio, 44121

  • Coeur d'Alene Arthritis Clinic

    Coeur d'Alene, Idaho, 83814

  • Southern Orthopaedic Sports Medicine

    Columbia, South Carolina, 29204

  • Ohio State U, Immunology/Rheumatology William Davis Medical Research Center

    Columbus, Ohio, 43210

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Alan Lichtbroun, MD

    East Brunswick, New Jersey, 08816

  • Center for Arthritis and Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Med Investigations, Inc.

    Fair Oaks, California, 95628

  • University of CT, Health Center

    Farmington, Connecticut, 06030-1310

  • DFW Wellness

    Fort Worth, Texas, 76108

  • North Orange County Research Institute, Inc.

    Fullerton, California, 92835

  • Center for Musculoskeletal Pain Research

    Gainesville, Florida, 32610

  • Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU

    Greenville, North Carolina, 27834

  • Arthritis Associates

    Hattiesburg, Mississippi, 39402

  • The Methodist Hospital System

    Houston, Texas, 77030

  • Houston Sleep Center

    Houston, Texas, 77063

  • R/D Clinical Research, Inc.

    Houston, Texas, 77074

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46254

  • Professional Clinical Research at Crystal Lake Health Center

    Interlochen, Michigan, 49643

  • Nerve Pro Research

    Irvine, California, 92618

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Suncoast Internal Medicine Consultants

    Largo, Florida, 33773

  • Central Kentucky Research Associates,Inc.

    Lexington, Kentucky, 40509

  • Drug Studies America

    Marietta, Georgia, 30066

  • AppleMed Research

    Miami, Florida, 33155

  • Cleveland Neuro-Sleep Research Institute Inc.

    Middleburg Heights, Ohio, 44130

  • Drug Research and Analysis Corporation

    Montgomery, Alabama, 36106

  • Northridge Neurological Center

    Northridge, California, 91325

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Compass Research

    Orlando, Florida, 32806

  • Bluegrass Internal Medicine

    Owensboro, Kentucky, 42303

  • dba 21st Century Neurology

    Phoenix, Arizona, 85004

  • Arroyo Medical Group

    Pismo Beach, California, 93449

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Oregon Health Sciences University School of Medicine

    Portland, Oregon, 97239

  • Capital Clinical Research Associates

    Rockville, Maryland, 20852

  • Northern California Research

    Sacramento, California, 95821

  • Sacramento Research Medical Group

    Sacramento, California, 95825

  • Sun Research Institute

    San Antonio, Texas, 78215

  • University of Texas Health Science Center

    San Antonio, Texas, 78229

  • Arthritis & Osteoporosis Center of South Texas

    San Antonio, Texas, 78232

  • Medex Healthcare Research, Inc

    St Louis, Missouri, 63117

  • St. John's Mercy Health System

    St Louis, Missouri, 63141

  • Clinical Research Group of St. Petersburg, Inc.

    St. Petersburg, Florida, 33707

  • Clinical Health Research, LLC

    Sugarland, Texas, 77479

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Lake Rheumatology

    Tavares, Florida, 32778

  • Cotton-O'neil Clinical Research center

    Topeka, Kansas, 66606

  • North Shore University Hospital, North Shore Pain Services

    Valley Stream, New York, 11580

  • Center for Arthritis and Rheumatism

    Vero Beach, Florida, 32962

  • Arthritis and Osteoporosis Clinic, Research Center of Central Texas

    Waco, Texas, 76708

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • Founders Research

    Yardley, Pennsylvania, 19067

  • Florida Medical Clinic, P.A., Clinical Research Division

    Zephyrhills, Florida, 33542

Other trials in United States

United Kingdom10 sites

  • Barnsley District General Hospital, Rheumatology Department

    Barnsley, S75 2EP

  • Royal National Hospital for Rheumatic Diseases NHS

    Bath, BA1 1RL

  • Lever Chambers Centre for Health

    Bolton

  • King's College London

    London, SE5 9RJ

  • 4 West Kennedy Clinical Trial unit

    London

  • King College London

    London

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Freeman Hospital

    Newcastle upon Tyne

  • Philip Arnold Unit

    Poole, BH15 2JB

  • Poole General Hospital

    Poole

Other trials in United Kingdom

Germany9 sites

  • Schlosspark-Klinik

    Berlin

  • Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie

    Böblingen

  • Intensivmedizin der Uniklinik Koln

    Cologne

  • Praxis Dr. Wiedeking

    Essen

  • Praxis fur Innere Medizin und Rheumatologie

    Gräfelfing

  • Gemeinschaftspraxis Schmerzzentrum

    Hamburg

  • Rheumazentrum am Krankenhaus Bad Doberan

    Hohenfelde - Bad Doberan

  • Praxisklinik Dr. Weiss

    Mannheim

  • Praxis Dr. Sohn

    Schwalmtal

Other trials in Germany

Spain9 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Instituto Ferran de Reumatologia

    Barcelona

  • Hospital Universitario de Guadalajara

    Guadalajara

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria

  • Hospital Civil de malaga

    Málaga

  • Hospital Central de Asturias

    Oviedo

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela

Other trials in Spain

France7 sites

  • Rhumatologie

    Amiens

  • CHU de Grenoble-hopital Sud

    Échirolles

  • Hopital Claude Huriez Service de medecine Interne

    Lille

  • Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord

    Nantes

  • Hopital Pasteue - Pavillon O

    Nice

  • Hopital Hotel Dieu service de medecine interne

    Paris

  • CHU Hopital de Rangueil

    Toulouse

Other trials in France

Poland6 sites

  • Wojewodzki Szpital Zespolony

    Elblag

  • Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny

    Katowice

  • Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny

    Poznan

  • w Szczecinie

    Szczecinie

  • NZOZ Nasz Lekarz

    Torun

  • Instytut Reumatologii

    Warsaw

Other trials in Poland

Italy2 sites

  • Azienda Ospedaliera Luigi Sacco

    Milan

  • Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara

    Pisa

Other trials in Italy

Netherlands2 sites

  • Amphia Ziekenhuis

    Breda

  • Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis

    Enschede

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

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.

Read the 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.

Conditions
Fibromyalgia
Being tested
placebo, Xyrem®
Keywords
FMS, Fibro, pain, Body pain, tenderness, stiffness, muscular pain, joint pain
Medical subject headings
Fibromyalgia, Pain, Myalgia, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    Oral Solution

  • Xyrem®Drug

    two doses

Study groups in NCT00423813
Study groupRoleWhat they receive
1Placebo comparatorNot described
Receives: Drug: placebo
2ExperimentalNot described
Receives: Drug: Xyrem®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionApr 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
573 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423813
Sponsor's protocol ID
06-009
Status last verified
Dec 2011
First submitted
16 Jan 2007
Last updated
24 Jan 2012
Data monitoring committee
No

Publications

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xyrem® in people with Fibromyalgia, run by Jazz Pharmaceuticals at 116 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, United Kingdom, Germany, Spain, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00423813, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.

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