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

January 20, 2012 updated by: Jazz Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
573

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens Cedex 1, France
        • Rhumatologie
      • Echirolles Cedex, France
        • Chu de Grenoble-Hopital Sud
      • Lille Cedex, France
        • Hopital Claude Huriez Service de medecine Interne
      • Nantes Cedex 2, France
        • Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord
      • Nice Cedex 1, France
        • Hopital Pasteue - Pavillon O
      • Paris Cedex 04, France
        • Hopital Hotel Dieu service de medecine interne
      • Toulouse Cedex 9, France
        • CHU Hopital de Rangueil
  • Germany
      • Berlin, Germany
        • Schlosspark-Klinik
      • Boblingen, Germany
        • Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie
      • Essen, Germany
        • Praxis Dr. Wiedeking
      • Grafelfing, Germany
        • Praxis fur Innere Medizin und Rheumatologie
      • Hamburg, Germany
        • Gemeinschaftspraxis Schmerzzentrum
      • Hohenfelde - Bad Doberan, Germany
        • Rheumazentrum am Krankenhaus Bad Doberan
      • Koln, Germany
        • Intensivmedizin der Uniklinik Koln
      • Mannheim, Germany
        • Praxisklinik Dr. Weiss
      • Schwalmtal, Germany
        • Praxis Dr. Sohn
  • Italy
      • Milano, Italy
        • Azienda Ospedaliera Luigi Sacco
      • Pisa, Italy
        • Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara
  • Netherlands
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Enschede, Netherlands
        • Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis
  • Poland
      • Elblag, Poland
        • Wojewodzki Szpital Zespolony
      • Katowice, Poland
        • Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny
      • Poznan, Poland
        • Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny
      • Szczecinie, Poland
        • w Szczecinie
      • Torun, Poland
        • NZOZ Nasz Lekarz
      • Warszawa, Poland
        • Instytut Reumatologii
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Instituto Ferran de Reumatologia
      • Guadalajara, Spain
        • Hospital Universitario de Guadalajara
      • La Laguna, Spain
        • Hospital Universitario de Canarias
      • Las Palmas de Gran Canaria, Spain
        • Hospital Universitario de Gran Canaria Dr. Negrín
      • Malaga, Spain
        • Hospital Civil de Málaga
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Santiago de Compostela, Spain
        • Hospital Clínico Universitario de Santiago
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
        • Barnsley District General Hospital, Rheumatology Department
      • Bath, United Kingdom, BA1 1RL
        • Royal National Hospital for Rheumatic Diseases NHS
      • Bolton, United Kingdom
        • Lever Chambers Centre for Health
      • London, United Kingdom, SE5 9RJ
        • King's College London
      • London, United Kingdom
        • 4 West Kennedy Clinical Trial unit
      • London, United Kingdom
        • King College London
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Newcastle upon tyne, United Kingdom
        • Freeman Hospital
      • Poole, United Kingdom
        • Poole General Hospital
      • Poole, United Kingdom, BH15 2JB
        • Philip Arnold Unit
  • United States
    • Alabama
      • Auburn, Alabama, United States, 36830
        • East Alabama Arthritis Center
      • Birmingham, Alabama, United States, 35209
        • Capstone Clinical Trials, Inc.
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corporation
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Dba 21st Century Neurology
    • California
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Fair Oaks, California, United States, 95628
        • Med Investigations, Inc.
      • Fullerton, California, United States, 92835
        • North Orange County Research Institute, Inc.
      • Irvine, California, United States, 92618
        • Nerve Pro Research
      • Northridge, California, United States, 91325
        • Northridge Neurological Center
      • Pismo Beach, California, United States, 93449
        • Arroyo Medical Group
      • Sacramento, California, United States, 95821
        • Northern California Research
      • Sacramento, California, United States, 95825
        • Sacramento Research Medical Group
    • Connecticut
      • Farmington, Connecticut, United States, 06030-1310
        • University of CT, Health Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Center for Musculoskeletal Pain Research
      • Jacksonville, Florida, United States, 32257
        • Florida Institute of Medical Research
      • Largo, Florida, United States, 33773
        • Suncoast Internal Medicine Consultants
      • Miami, Florida, United States, 33155
        • AppleMed Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • St. Petersburg, Florida, United States, 33707
        • Clinical Research Group of St. Petersburg, Inc.
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
      • Tavares, Florida, United States, 32778
        • Lake Rheumatology
      • Vero Beach, Florida, United States, 32962
        • Center for Arthritis and Rheumatism
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A., Clinical Research Division
    • Georgia
      • Marietta, Georgia, United States, 30066
        • Drug Studies America
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Coeur D'Alene Arthritis Clinic
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Fibromyalgia Treatment Centers of America
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Investigative Clinical Research of Indiana, LLC
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Center For Arthritis and Osteoporosis
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates,Inc.
      • Owensboro, Kentucky, United States, 42303
        • Bluegrass Internal Medicine
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Louisiana Sleep Foundation
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research Associates
    • Michigan
      • Benzonia, Michigan, United States, 49616
        • Professional Clinical Research at Cyrstal Lake Health Center
      • Bingham Farms, Michigan, United States, 48025
        • Quest Research Institute
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Research
      • Interlochen, Michigan, United States, 49643
        • Professional Clinical Research at Crystal Lake Health Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39402
        • Arthritis Associates
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • St. John's Mercy Health System
      • St. louis, Missouri, United States, 63117
        • Medex Healthcare Research, Inc
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc.
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
      • East Brunswick, New Jersey, United States, 08816
        • Alan Lichtbroun, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Valley Stream, New York, United States, 11580
        • North Shore University Hospital, North Shore Pain Services
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Boone, North Carolina, United States, 28607-0000
        • Appalachian Regional Medical Associates
      • Greenville, North Carolina, United States, 27834
        • Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Hightop Medical Research Center
      • Cleveland, Ohio, United States, 44121
        • Health Research Associates, LLC (HRA)
      • Columbus, Ohio, United States, 43210
        • Ohio State U, Immunology/Rheumatology William Davis Medical Research Center
      • Middleburg Heights, Ohio, United States, 44130
        • Cleveland Neuro-Sleep Research Institute Inc.
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University School of Medicine
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Tri State Medical Group, Inc.
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Yardley, Pennsylvania, United States, 19067
        • Founders Research
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Southern Orthopaedic Sports Medicine
    • Texas
      • Austin, Texas, United States, 78756
        • Neurology Future Research Trials
      • Fort Worth, Texas, United States, 76108
        • DFW Wellness
      • Houston, Texas, United States, 77030
        • The Methodist Hospital System
      • Houston, Texas, United States, 77074
        • R/D Clinical Research, Inc.
      • Houston, Texas, United States, 77063
        • Houston Sleep Center
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center
      • San Antonio, Texas, United States, 78232
        • Arthritis & Osteoporosis Center of South Texas
      • Sugarland, Texas, United States, 77479
        • Clinical Health Research, LLC
      • Waco, Texas, United States, 76708
        • Arthritis and Osteoporosis Clinic, Research Center of Central Texas
    • Virginia
      • Arlington, Virginia, United States, 22204
        • Alben Goldstein, MD, FACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 2
Drug: Xyrem®
two doses
PLACEBO_COMPARATOR: 1
Drug: placebo
Oral Solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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