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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00803023
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : August 16, 2011
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
Jazz Pharmaceuticals

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Sodium Oxybate Drug: Sodium Oxybate & 6 Tablets Drug: Sodium Oxybate & 8 Tablets Drug: Sodium Oxybate Oral Solution (6 grams) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : July 2010

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Tolerability Assessed by Adverse Events [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803023


Locations
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Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
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Study Director: Grace Wang, MD Jazz Pharmaceuticals
More Information
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Responsible Party: Sr. Director of Clinical Development - Psychiatry, Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00803023    
Other Study ID Numbers: 08-004
First Posted: December 5, 2008    Key Record Dates
Results First Posted: August 16, 2011
Last Update Posted: August 19, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
 Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs