Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Sodium Oxybate; Drug: Sodium Oxybate & 6 Tablets; Drug: Sodium Oxybate Oral Solution (6 grams); Drug: Sodium Oxybate & 8 Tablets

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85004
      • Dba 21st Century Neurology
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Anaheim, California, United States, 92801
      • Orange County Clinical Trials
    • Fair Oaks, California, United States, 95628
      • Med Investigations, Inc.
    • Northridge, California, United States, 91325
      • Northridge Neurological Center
    • Pismo Beach, California, United States, 93449
      • Arroyo Medical Group, Inc.
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Sacramento, California, United States, 95825
      • Superior Research, LLC
    • Santa Ana, California, United States, 92705
      • Apex Research Institute
  • Florida
    • Fort Meyers, Florida, United States, 33916
      • Clinical Physiology Associates Clinical Study
    • Orlando, Florida, United States, 32806
      • Compass Research
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Medical Group - Clinical Research
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves Gilbert Clinic
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth Biomedical Resaerch, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Louisiana Sleep Foundation
  • Michigan
    • Interlochen, Michigan, United States, 49643
      • Professional Clinical Research - Interlochen
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc.
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45224
      • Hill Top Physicians Inc. / Hihgtop Medical Research Center
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Mechanicsburg, Pennsylvania, United States, 17055
      • Central Pennsylvania Clinic
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Southern Orthopeadic Sports
    • Rock Hill, South Carolina, United States, 29732
      • The Carolina Center for Rheumatology & ArthiritisCare PA
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
  • Texas
    • Austin, Texas, United States, 78756
      • FutureSearch Trials of Neurology
    • Fort Worth, Texas, United States, 76108
      • DFW Wellness
    • Houston, Texas, United States, 77063
      • Houston Sleep Clinic
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • Sugar Land, Texas, United States, 77479
      • Clinical Health Research, LLC
  • Washington
    • Renton, Washington, United States, 98055
      • Pacific Rheumatology Associates

Participation Criteria

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:

• Subject is able to understand the written informed consent
• Subject is 18 years of age or older.
• Subject meets the ACR criteria for fibromyalgia
• Subject is willing to discontinue prohibited by the protocol
• Subject agrees to use only non-sedating over-the-counter (OTC)medication
• Subject is willing to abstain from the ingestion of alcohol for the duration of the trial.

Exclusion Criteria:

• Subject has protocol prohibited medical & psychiatric conditions that would exclude subject
• Subject has a current or past history of a substance use disorder including alcohol abuse
• Subject has a clinically significant history of seizure disorder either past or present
• Female subject who is pregnant, nursing or lactating.
• Subject is diagnosed with sleep apnea
• Subject is unable to discontinue protocol prohibited medications
• Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
• Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form.
• Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid).
• Subject is on a sodium-restricted diet.
• Subject has abnormal liver function test or other abnormal lab values
• Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed.
• Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms.
• Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Sodium Oxybate Oral Solution (4.5 grams)	Drug: Sodium Oxybate; 4.5 grams per night taken in two equally divided doses
EXPERIMENTAL: 2; Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)	Drug: Sodium Oxybate & 6 Tablets; 4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
EXPERIMENTAL: 3; Sodium Oxybate Oral Solution (6 grams)	Drug: Sodium Oxybate Oral Solution (6 grams); 6 grams per night taken in two equally divided doses
EXPERIMENTAL: 4; Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)	Drug: Sodium Oxybate & 8 Tablets; 6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability Assessed by Adverse Events	4 weeks

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: December 3, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (ESTIMATE): December 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2011
• Last Update Submitted That Met QC Criteria: August 17, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Adjuvants, Anesthesia; Sodium Oxybate
• Other Study ID Numbers: 08-004 (Other Identifier: Prostate Cancer Clinical Trials Consortium Protocol Number)