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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sodium Oxybate Oral Solution (4.5 grams) |
|
| 2 | Experimental | Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams) |
|
| 3 | Experimental | Sodium Oxybate Oral Solution (6 grams) |
|
| 4 | Experimental | Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Oxybate | Drug | 4.5 grams per night taken in two equally divided doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Assessed by Adverse Events | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Wang, MD | Jazz Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dba 21st Century Neurology | Phoenix | Arizona | 85004 | United States | ||
| Arizona Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4.5g SXB | Sodium Oxybate Oral Solution (4.5 grams/night) |
| FG001 | 4.5g SXB + 6 Tablets | Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sodium Oxybate & 6 Tablets |
| Drug |
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night |
|
| Sodium Oxybate & 8 Tablets | Drug | 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) | Drug | 6 grams per night taken in two equally divided doses |
|
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Orange County Clinical Trials | Anaheim | California | 92801 | United States |
| Med Investigations, Inc. | Fair Oaks | California | 95628 | United States |
| Northridge Neurological Center | Northridge | California | 91325 | United States |
| Arroyo Medical Group, Inc. | Pismo Beach | California | 93449 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Superior Research, LLC | Sacramento | California | 95825 | United States |
| Apex Research Institute | Santa Ana | California | 92705 | United States |
| Clinical Physiology Associates Clinical Study | Fort Meyers | Florida | 33916 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Memorial Medical Group - Clinical Research | South Bend | Indiana | 46601 | United States |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Commonwealth Biomedical Resaerch, LLC | Madisonville | Kentucky | 42431 | United States |
| Louisiana Sleep Foundation | Baton Rouge | Louisiana | 70809 | United States |
| Professional clinical Research - Interlochen | Interlochen | Michigan | 49643 | United States |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | United States |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Hill Top Physicians Inc. / Hihgtop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Central Pennsylvania Clinic | Mechanicsburg | Pennsylvania | 17055 | United States |
| Southern Orthopeadic Sports | Columbia | South Carolina | 29204 | United States |
| The Carolina Center for Rheumatology & ArthiritisCare PA | Rock Hill | South Carolina | 29732 | United States |
| Clinsearch | Chattanooga | Tennessee | 37421 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78756 | United States |
| DFW Wellness | Fort Worth | Texas | 76108 | United States |
| Houston Sleep Clinic | Houston | Texas | 77063 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Clinical Health Research, LLC | Sugar Land | Texas | 77479 | United States |
| Pacific Rheumatology Associates | Renton | Washington | 98055 | United States |
| FG002 | 6g SXB | Sodium Oxybate Oral Solution (6 grams/night) |
| FG003 | 6g SXB + 8 Tablets | Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4.5g SXB | Sodium Oxybate Oral Solution (4.5 grams/night) |
| BG001 | 4.5g SXB + 6 Tablets | Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night |
| BG002 | 6g SXB | Sodium Oxybate Oral Solution (6 grams/night) |
| BG003 | 6g SXB + 8 Tablets | Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Posted | Number | participants | 4 weeks |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Tolerability Assessed by Adverse Events | Not Posted | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4.5g SXB | Sodium Oxybate Oral Solution (4.5 grams/night) | 1 | 32 | 12 | 32 | ||
| EG001 | 4.5g SXB + 6 Tablets | Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night | 0 | 33 | 13 | 33 | ||
| EG002 | 6g SXB | Sodium Oxybate Oral Solution (6 grams/night) | 1 | 31 | 11 | 31 | ||
| EG003 | 6g SXB + 8 Tablets | Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night | 0 | 33 | 17 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Suicidal Behavior | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Edema Peripheral | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sinusitus | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Development | Jazz Pharmaceuticals | 650-496-3777 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
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| 40 - 49 |
|
| 50 - 64 |
|
| >=65 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Gastrointestinal Disorders |
|
| Diarrhea |
|
| Nausea |
|
| Vomiting |
|
| General Disorders & Administration Site Conditions |
|
| Fatigue |
|
| Edema Peripheral |
|
| Infections & Infestation |
|
| Sinusitis |
|
| Urinary Tract Infection |
|
| Injury, Posioning, & Procedural Complications |
|
| Investigations |
|
| Metabolism & Nutrition Disorders |
|
| Musculoskeletal & Connective tissue Disorders |
|
| Back Pain |
|
| Nervous System Disorders |
|
| Dizziness |
|
| Headache |
|
| Somnolence |
|
| Tremor |
|
| Psychiatric Disorders |
|
| Anxiety |
|
| Insomnia |
|
| Major Depression |
|
| Renal & Urinary Disorders |
|
| Respiratory, Thoracic, & Mediastinal Disorders |
|
| Pharyngolaryngeal Pain |
|
| Sinus Congestion |
|
| Skin & Subcutaneous Tissue Disorders |
|