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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803023
• Other study ID #: 08-004
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2008
• Last updated: August 17, 2011
• Start date: March 2010

Study information

• Verified date: August 2011
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Sodium Oxybate
4.5 grams per night taken in two equally divided doses
• Sodium Oxybate & 6 Tablets
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
• Sodium Oxybate & 8 Tablets
6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
• Sodium Oxybate Oral Solution (6 grams)
6 grams per night taken in two equally divided doses

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Orange County Clinical Trials	Anaheim	California
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Louisiana Sleep Foundation	Baton Rouge	Louisiana
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	Clinsearch	Chattanooga	Tennessee
United States	Hill Top Physicians Inc. / Hihgtop Medical Research Center	Cincinnati	Ohio
United States	Southern Orthopeadic Sports	Columbia	South Carolina
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Med Investigations, Inc.	Fair Oaks	California
United States	Clinical Physiology Associates Clinical Study	Fort Meyers	Florida
United States	DFW Wellness	Fort Worth	Texas
United States	Houston Sleep Clinic	Houston	Texas
United States	Professional clinical Research - Interlochen	Interlochen	Michigan
United States	Commonwealth Biomedical Resaerch, LLC	Madisonville	Kentucky
United States	Central Pennsylvania Clinic	Mechanicsburg	Pennsylvania
United States	Northridge Neurological Center	Northridge	California
United States	Quality Clinical Research, Inc	Omaha	Nebraska
United States	Compass Research	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Dba 21st Century Neurology	Phoenix	Arizona
United States	Arroyo Medical Group, Inc.	Pismo Beach	California
United States	Pacific Rheumatology Associates	Renton	Washington
United States	The Carolina Center for Rheumatology & ArthiritisCare PA	Rock Hill	South Carolina
United States	Northern California Research	Sacramento	California
United States	Superior Research, LLC	Sacramento	California
United States	Sun Research Institute	San Antonio	Texas
United States	Apex Research Institute	Santa Ana	California
United States	Memorial Medical Group - Clinical Research	South Bend	Indiana
United States	Clinical Health Research, LLC	Sugar Land	Texas
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects		4 weeks	Yes
Secondary	Tolerability Assessed by Adverse Events		4 weeks	Yes