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

December 21, 2011 updated by: Jazz Pharmaceuticals

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® 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

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

548

Phase

  • 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

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of N. AL, PC
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85004
        • Xenoscience, Inc. dba 21st Century Neurology
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Carmichael, California, United States, 95608
        • Northern California Research
      • Pasadena, California, United States, 91105
        • Pasadena Rehabilitation Institute
      • Pismo Beach, California, United States, 93449
        • Arroyo Medical Group
      • Sacramento, California, United States, 95825
        • Sacramento Research Medical Group
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
      • Santa Barbara, California, United States, 93110
        • Sansum Clinic
      • Whittier, California, United States, 90601
        • Robert E. Harris, MD Medical Corporation
    • Florida
      • Fort Meyers, Florida, United States, 33916
        • Clinical Physiology Associates Clinical Study Center
      • Ft. Lauderdale, Florida, United States, 33334
        • CRIA Research
      • Largo, Florida, United States, 33770
        • Innovative Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Plantation, Florida, United States, 33317
        • Sunrise Medical Research
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research, Inc
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Deerpath Physicians Group
      • Peoria, Illinois, United States, 61614
        • Balanced Health Research Center
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
      • Indianapolis, Indiana, United States, 46254
        • Investigative Clinical Research of Indiana, LLC
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves - Gilbert Clinic
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, Inc.
      • Madisonville, Kentucky, United States, 42431
        • Commonwealth Biomedical Reseach, LLC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • FutureCare Studies
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Michigan
      • Lansing, Michigan, United States, 48917
        • PCM Medical Services
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
      • St. Louis, Missouri, United States, 63141
        • St. John's Mercy Health System
      • St. Louis, Missouri, United States, 63117
        • Clayton Medical Associates
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc.
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • CCR Trials
      • Cherry Hill, New Jersey, United States, 08002
        • School of Osteopathic Medicine
      • Edison, New Jersey, United States, 08817
        • Anderson & Collins Clinical Research, Inc.
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC
      • Rochester, New York, United States, 14618
        • AAIR Research Center
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Carolina Bone and Joint
      • Charlotte, North Carolina, United States, 28226
        • Carolinas Research
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Radiant Research
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center, LLC
      • Mogadore, Ohio, United States, 44260
        • Radiant Research
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • PRO Research
      • Medford, Oregon, United States, 97504
        • Medford Medical Clinic, LLP
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Central Pennsylvania Clinical Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Research Center
      • Greer, South Carolina, United States, 29651
        • Radiant Research, Greer
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants, PLLC
    • Texas
      • Austin, Texas, United States, 78705
        • Walter M. Chase, MD
      • Austin, Texas, United States, 78756
        • Future Search Trials of Neurology Future Research Trials
      • Fort Worth, Texas, United States, 76108
        • DFW Wellness
      • Houston, Texas, United States, 77063
        • Houston Sleep Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Systems
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center
      • San Antonio, Texas, United States, 78205
        • Sun Research Institute
      • San Antonio, Texas, United States, 78217
        • Radiant Research San Antonio Northeast
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Fatigue Consultation Center
    • Washington
      • Kirkland, Washington, United States, 98034
        • Richard A. Neiman, MD, Inc.
      • Renton, Washington, United States, 98055
        • Pacific Rheumatolgy Associates, Inc.
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charrleston Internal Medicine

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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Xyrem®
two doses
Placebo Comparator: 1
Drug: Placebo
Oral Solution

What is the study measuring?

Primary Outcome Measures

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

Jazz Pharmaceuticals

Investigators

  • Principal Investigator: I. Jon Russell, PhD, MD, The University of Texas Health Science Center at San Antonio

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

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

August 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-008

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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