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This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.
Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.
This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.
Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xyrem (sodium oxybate) oral solution | Drug | Xyrem (sodium oxybate) oral solution |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Experiences | Number of Subjects with treatment-emergent adverse events. | continuous |
| Vital Signs | Average Respiratory Rate at 1 year. | At 1 year |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain and Sleep Diagnostic Centre | Toronto | Ontario | M8X 2W2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xyrem (Sodium Oxybate) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xyrem (Sodium Oxybate) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Adverse Experiences | Number of Subjects with treatment-emergent adverse events. | Posted | Number | participants | continuous |
|
|
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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 | Xyrem (Sodium Oxybate) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mortimer Mamelak, MD | Jazz Pharmaceuticals, Inc. | 650 496 3777 | roman.skowronski@jazzpharma.com |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D002385 | Cataplexy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Withdrawal by Subject |
|
| Planned Pregnancy |
|
| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Vital Signs | Average Respiratory Rate at 1 year. | Posted | Mean | Standard Deviation | Breaths per minute | At 1 year |
|
|
|
| 11 |
| 58 |
| 54 |
| 58 |
| Diverticulitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Enterocolitis Infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Delusional Disorder, Persecutory Type | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight Increase | Investigations | MedDRA | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| D004364 | Pharmaceutical Preparations |