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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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sodium Oxybate
Sodium Oxybate & 6 Tablets
Sodium Oxybate & 8 Tablets
Sodium Oxybate Oral Solution (6 grams)
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dba 21st Century Neurology
  • Arizona Research Center
  • Advanced Clinical Research Institute
  • Orange County Clinical Trials
  • Med Investigations, Inc.
  • Northridge Neurological Center
  • Arroyo Medical Group, Inc.
  • Northern California Research
  • Superior Research, LLC
  • Apex Research Institute
  • Clinical Physiology Associates Clinical Study
  • Compass Research
  • Memorial Medical Group - Clinical Research
  • Graves Gilbert Clinic
  • Commonwealth Biomedical Resaerch, LLC
  • Louisiana Sleep Foundation
  • Professional clinical Research - Interlochen
  • Quality Clinical Research, Inc
  • Albuquerque Neuroscience, Inc.
  • The Center for Clinical Research
  • Hill Top Physicians Inc. / Hihgtop Medical Research Center
  • Altoona Center for Clinical Research
  • Central Pennsylvania Clinic
  • Southern Orthopeadic Sports
  • The Carolina Center for Rheumatology & ArthiritisCare PA
  • Clinsearch
  • FutureSearch Trials of Neurology
  • DFW Wellness
  • Houston Sleep Clinic
  • Sun Research Institute
  • Clinical Health Research, LLC
  • Pacific Rheumatology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Sodium Oxybate Oral Solution (4.5 grams)

Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)

Sodium Oxybate Oral Solution (6 grams)

Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)

Outcomes

Primary Outcome Measures

Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects

Secondary Outcome Measures

Tolerability Assessed by Adverse Events

Full Information

First Posted
December 3, 2008
Last Updated
August 17, 2011
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00803023
Brief 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
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sodium Oxybate Oral Solution (4.5 grams)
Arm Title
2
Arm Type
Experimental
Arm Description
Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
Arm Title
3
Arm Type
Experimental
Arm Description
Sodium Oxybate Oral Solution (6 grams)
Arm Title
4
Arm Type
Experimental
Arm Description
Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate
Intervention Description
4.5 grams per night taken in two equally divided doses
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate & 6 Tablets
Intervention Description
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate & 8 Tablets
Intervention Description
6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate Oral Solution (6 grams)
Intervention Description
6 grams per night taken in two equally divided doses
Primary Outcome Measure Information:
Title
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Tolerability Assessed by Adverse Events
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Wang, MD
Organizational Affiliation
Jazz Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Dba 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Orange County Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Med Investigations, Inc.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Northridge Neurological Center
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Arroyo Medical Group, Inc.
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Superior Research, LLC
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Clinical Physiology Associates Clinical Study
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Memorial Medical Group - Clinical Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Commonwealth Biomedical Resaerch, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Louisiana Sleep Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Professional clinical Research - Interlochen
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49643
Country
United States
Facility Name
Quality Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hill Top Physicians Inc. / Hihgtop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Central Pennsylvania Clinic
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Southern Orthopeadic Sports
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
The Carolina Center for Rheumatology & ArthiritisCare PA
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Clinsearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
DFW Wellness
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76108
Country
United States
Facility Name
Houston Sleep Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Health Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Pacific Rheumatology Associates
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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