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Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00087555
First received: July 12, 2004
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.


Condition Intervention Phase
Fibromyalgia
Drug: Xyrem (sodium oxybate) oral solution
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C). [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]

    The percentage of participants who met all 3 of the following criteria:

    Reduction of >=20% from baseline to week 8 in both PVAS & FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"



Enrollment: 195
Study Start Date: July 2004
Study Completion Date: January 2006
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Sodium oxybate 6.0 g per day.
Drug: Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
Placebo Comparator: 3
Placebo (one of two doses matching active treatment by volume).
Drug: Placebo
Placebo one of two doses matching active treatment by volume for 8 weeks.
Experimental: 1
Sodium oxybate 4.5 g per day.
Drug: Xyrem (sodium oxybate) oral solution
Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.

Detailed Description:

Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Sign & date informed consent
  • Willing & able to complete trial as described in protocol
  • > 18 years of age
  • Meet American College of Rheumatology criteria for Fibromyalgia [Widespread pain for at least 3 months, including all of the following: (1) Pain on right & left sides of body; (2) Pain above & below waist; (3) Pain in axial skeleton; 4) Pain on digital palpation with approximately 4kg force in at least 11 of 18 tender point sites]
  • (Study continuation) Have an average VAS pain score > 4 on a scale of 0 to 10 as recorded in patient diary the last week before Visit 4.
  • Discontinue all prescription medication taken for fibromyalgia, including opiates, benzodiazepines, anticonvulsants taken for pain, antidepressants, cyclobenzaprine (Flexeril), and/or tramadol (Ultram) until study completion
  • Continue all pre-existing nutritional and/or exercise regimens and/or behavioral, massage, acupuncture, physical or cognitive therapies on an unchanged, consistent & regular schedule throughout study
  • Use only acetaminophen or over-the-counter non-steroidal anti-inflammatory drugs as rescue pain medications & to limit dose to the labeled over-the-counter maximum. Aspirin may only be used as a cardiac protectant; formulations with caffeine are excluded.
  • Forego ingestion of alcohol for duration of study.
  • Fertile females must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) for duration of trial.

Exclusion Criteria

  1. Have any of the following medical conditions:

    • Other rheumatic disease, such as rheumatoid arthritis, osteoarthritis, or systemic lupus erythematosis
    • Uncontrolled hypo- or hyper-thyroidism of any type
    • Unstable cardiovascular, endocrine, neoplastic (excluding localized basal cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place patient at risk during trial or compromise objectives outlined in protocol
    • Myocardial infarction within last six months
    • On their screening PSG (polysomnogram) have an Apnea Index greater than 10 per hour or an Apnea Hypopnea Index greater than 15 per hour. Note: patients with sleep apnea are not excluded if their indices are below these thresholds while sleeping with CPAP (Continuous Positive Airway Pressure) and they are compliant with CPAP therapy.
    • Problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
    • If a patient will have to discontinue antidepressant medication taken for depression, the investigator must make an evaluation as to any risks from cessation of anti-depressant therapy. If, in the opinion of the investigator, a reasonable risk of resultant patient harm exists, patient is excluded from study participation
    • Current or recent history of substance abuse including alcohol abuse
    • History of seizure disorder, history of head trauma, migraine headaches or intracranial surgery, & are taking anticonvulsants
    • Succinic semialdehyde dehydrogenase deficiency
  2. Have taken any of these therapies:

    • gamma-hydroxybutyrate (sodium oxybate) in 30 days prior to signing informed consent
    • any investigational therapy in 30 days prior to signing informed consent
    • ever taken anticonvulsants to treat epilepsy or any other convulsions
  3. Unwilling to stop these therapies during course of trial:

    • anticonvulsants prescribed solely for pain
    • all antidepressants
    • medication for sleep
  4. Have any of the following clinical laboratory results:

    • Serum creatinine > 2.0 mg/dL
    • TSH (Thyroid Stimulating Hormone) < 0.3 μU/mL OR TSH > 6 μU/mL
    • abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal)
    • elevated serum bilirubin (more than 1.5 times the upper limit of normal)
    • pre-trial ECG with arrhythmia, greater than a first degree AV block
    • positive pregnancy test at any time during trial
  5. Have any of the following socio-economic factors:

    • Pending worker's compensation litigation or related other monetary settlements
    • Have an occupation that requires variable shift work or routine night shifts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087555

Locations
United States, Arizona
Radiant Research
Scottsdale, Arizona, United States, 85251
United States, California
Osteoporosis Medical Center
Beverly Hills, California, United States, 90211
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
Radiant Research, Inc.
West Palm Beach, Florida, United States, 33407
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71130-3932
United States, New Jersey
Richard N. Podell, MD
Springfield, New Jersey, United States, 07081
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Alvin Daughtridge Arthritis Center
Lenoir, North Carolina, United States, 28645
C.A.R.E. Center
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cleveland Sleep Center
Middlebrook Heights, Ohio, United States, 44130
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Abigail Rebecca Neiman, MD
Katy, Texas, United States, 77450
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
United States, Utah
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital
Sandy, Utah, United States, 84094
United States, Washington
Pacific Rheumatology Research, Inc.
Renton, Washington, United States, 98055
Seattle Rheumatology Associates
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Study Director: Yanping Zheng, MD Jazz Pharmaceuticals, Inc
  More Information

Publications:
Responsible Party: Senior Director Clinical Development, Jazz Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00087555     History of Changes
Other Study ID Numbers: OMC-SXB-26
Study First Received: July 12, 2004
Results First Received: October 17, 2011
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jazz Pharmaceuticals:
Fibromyalgia
Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Pharmaceutical Solutions
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014