Clinical trial NCT00803023: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
timeFrame: 4 weeks
Secondary outcomes:
measure: Tolerability Assessed by Adverse Events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dba 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Fair Oaks
country: United States
facility: Med Investigations, Inc.
state: California
city: Northridge
country: United States
facility: Northridge Neurological Center
state: California
city: Pismo Beach
country: United States
facility: Arroyo Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Sacramento
country: United States
facility: Superior Research, LLC
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Fort Meyers
country: United States
facility: Clinical Physiology Associates Clinical Study
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: South Bend
country: United States
facility: Memorial Medical Group - Clinical Research
state: Indiana
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Resaerch, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana Sleep Foundation
state: Louisiana
city: Interlochen
country: United States
facility: Professional clinical Research - Interlochen
state: Michigan
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Hill Top Physicians Inc. / Hihgtop Medical Research Center
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Central Pennsylvania Clinic
state: Pennsylvania
city: Columbia
country: United States
facility: Southern Orthopeadic Sports
state: South Carolina
city: Rock Hill
country: United States
facility: The Carolina Center for Rheumatology & ArthiritisCare PA
state: South Carolina
city: Chattanooga
country: United States
facility: Clinsearch
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Fort Worth
country: United States
facility: DFW Wellness
state: Texas
city: Houston
country: United States
facility: Houston Sleep Clinic
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Sugar Land
country: United States
facility: Clinical Health Research, LLC
state: Texas
city: Renton
country: United States
facility: Pacific Rheumatology Associates
state: Washington
Study officials:
affiliation: Jazz Pharmaceuticals
name: Grace Wang, MD
role: STUDY_DIRECTOR
References: