Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004417-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Oxybate | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Oxybate (Xyrem) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) | An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3. | After 1 month of treatment (Visit 3) |
| The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) | An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4. | After 3 months of treatment (Visit 4) |
| Measure | Description | Time Frame |
|---|---|---|
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH. | Baseline (Visit 2) - approximately 1 day |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3 |
Not provided
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liège | Belgium |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Participant Flow refers to the Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication.
This single-center, therapeutic, exploratory study started to enroll subjects in April 2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Oxybate | Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Characteristics refer to the Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Oxybate | Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Visit 2) - approximately 1 day |
|
|
Adverse Events were collected from Visit 1 through the end of the study (approximately 4 months).
Adverse Events refer to the Safety Population which is identical to the Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Oxybate | Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA9.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1 844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH. |
| Visit 3 (approximately 1 month) |
| The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4 | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH. | Visit 4 (approximately 3 months) |
| Cortisol Measured at Baseline (Visit 2) | Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol. | Baseline (Visit 2) - approximately 1 day |
| Cortisol Measured at Visit 3 | Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol. | Visit 3 (approximately 1 month) |
| Cortisol Measured at Visit 4 | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol. | Visit 4 (approximately 3 months) |
| The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3 | An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4 | An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3 | An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4 | An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Prolactin Measured in Fasting Conditions at Baseline (Visit 2) | An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Prolactin Measured in Fasting Conditions at Visit 3 | An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Prolactin Measured in Fasting Conditions at Visit 4 | An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3 | An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4 | An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3 | An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4 | An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Osmolality Measured in Fasting Conditions at Baseline (Visit 2) | An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Osmolality Measured in Fasting Conditions at Visit 3 | An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Osmolality Measured in Fasting Conditions at Visit 4 | An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2. | Baseline (Visit 2) - approximately 1 day |
| Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3. | Visit 3 (approximately 1 month) |
| Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4. | Visit 4 (approximately 3 months) |
| The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study | An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below. | Visit 1 through the end of the study (approximately 4 months) |
| The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study | An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below. | Visit 1 through the end of the study (approximately 4 months) |
| The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study | A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect | Visit 1 through the end of the study (approximately 4 months) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) | An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | After 1 month of treatment (Visit 3) |
|
|
|
| Primary | The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) | An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | After 3 months of treatment (Visit 4) |
|
|
|
| Secondary | The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) | Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3 | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4 | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | Cortisol Measured at Baseline (Visit 2) | Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ug/L | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | Cortisol Measured at Visit 3 | Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ug/L | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | Cortisol Measured at Visit 4 | Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ug/L | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3 | An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | pg/mL | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4 | An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | pg/mL | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ug/L | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3 | An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ug/L | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4 | An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | ug/L | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Prolactin Measured in Fasting Conditions at Baseline (Visit 2) | An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mUI/L | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Prolactin Measured in Fasting Conditions at Visit 3 | An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mUI/L | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Prolactin Measured in Fasting Conditions at Visit 4 | An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mUI/L | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | uU/mL | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3 | An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | uU/mL | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4 | An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | uU/mL | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3 | An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | pg/mL | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4 | An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | pg/mL | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Osmolality Measured in Fasting Conditions at Baseline (Visit 2) | An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mosm/kg | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Osmolality Measured in Fasting Conditions at Visit 3 | An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mosm/kg | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Osmolality Measured in Fasting Conditions at Visit 4 | An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mosm/kg | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2) | An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mg/L | Baseline (Visit 2) - approximately 1 day |
|
|
|
| Secondary | Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mmol/L | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mg/L | Visit 3 (approximately 1 month) |
|
|
|
| Secondary | Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mmol/L | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4 | An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mg/L | Visit 4 (approximately 3 months) |
|
|
|
| Secondary | The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study | An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Number | Participants | Visit 1 through the end of the study (approximately 4 months) |
|
|
|
| Secondary | The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study | An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below. | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Number | Participants | Visit 1 through the end of the study (approximately 4 months) |
|
|
|
| Secondary | The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study | A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect | Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication. | Posted | Number | Participants | Visit 1 through the end of the study (approximately 4 months) |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 15 |
| 25 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA9.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA9.0 | Non-systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| Title | Measurements |
|---|---|
|
| 4h |
|
| 8h |
|
| 12h |
|
| 16h |
|
| 20h |
|
| Title | Measurements |
|---|---|
|
| 4h |
|
| 8h |
|
| 12h |
|
| 16h |
|
| 20h |
|
| Title | Measurements |
|---|---|
|
| 4h |
|
| 8h |
|
| 12h |
|
| 16h |
|
| 20h |
|
| Title | Measurements |
|---|---|
|
| 4h |
|
| 8h |
|
| 12h |
|
| 16h |
|
| 20h |
|
| Title | Measurements |
|---|---|
|
| 4h |
|
| 8h |
|
| 12h |
|
| 16h |
|
| 20h |
|
| Title | Measurements |
|---|---|
|
| 4h |
|
| 8h |
|
| 12h |
|
| 16h |
|
| 20h |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|