Migraine
Conditions
Keywords
Migraine with and without aura
Brief summary
Study Objectives: 1. The primary objective is to characterize the pharmacokinetics of a single oral administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis of episodic migraine with or without aura. 2. The secondary objectives are to determine: 1. The safety and tolerability of Cambia from a single dose 2. Three-month safety evaluation of Cambia in outpatient usage in this population
Interventions
DRUGDiclofenac Potassium for Oral Solution
NSAID
Sponsors
Depomed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥12 and ≤17 years of age at screening. 2. Subject diagnosed with episodic migraine with or without aura for at least 3 months (migraine defined based on the International classification of headache disorders-II 1.2.1 or 1.1). 3. Subject has 14 or fewer headache days per month. 4. Subject receiving prophylactic treatment for migraine may be included. 5. If female, is not of childbearing potential (defined as premenarchal) or if of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Study Day 1, if the Screening visit and Day 1 are not on the same day, and must use medically acceptable methods of birth control as listed below and agrees to continue its use throughout the study:1) hormonal methods (e.g., oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full menstrual cycle before study drug administration), 2) Total abstinence from sexual intercourse since the last menses before study drug administration, 3) intrauterine device, 4) double-barrier method (e.g., condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream). 6. Subject's legally authorized representative (e.g., parent, guardian) must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB), and the subject must sign an assent (if appropriate), before the commencement of any study assessment. 7. Subject's legally authorized representative (e.g., parent, guardian) and subject (if appropriate), is able to read and understand the study procedures and requirements and adhere to the protocol requirements and procedures.
Exclusion criteria
1. Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, or any nonsteroidal anti inflammatory drugs (NSAIDs); history of NSAID induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to the non-active ingredients of the study medication. 2. Subject is pregnant or lactating or considered at risk of pregnancy. 3. Subject has been under an inconsistent dosing regimen of prophylactic treatment for migraine. 4. Subject has headache symptoms likely due to, or aggravated by, traumatic injury to the head or neck region, such as whiplash, within the last six months; 5. Subject has or is suspected of having a secondary headache. 6. Subject has significant abnormal findings during the neurological exam at screening. 7. Subject has a history of any GI event (e.g., perforation, obstruction, bleed) before Screening that, in the opinion of the investigator, would make the subject unsuitable for study participation. 8. Subject is receiving any medication that, in the opinion of the investigator, may cause a clinically significant condition when used concomitantly with diclofenac (e.g., aspirin, anticoagulants, ACE inhibitors, methotrexate, cyclosporine, furosemide, lithium). 9. Subject is and has been receiving a medication that is known to strongly inhibit and/or induce cytochrome P450 2C9 such that it might unpredictably affect the pharmacokinetics of diclofenac (e.g., fluconazole, amiodarone, oxandrolone, sulfipyrazone as inhibitors and rifampin as an inducer). 10. Subject has any condition or any laboratory abnormality that would, in the opinion of the investigator, contraindicate study participation. 11. Subject has impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥ 3 times the upper limit of normal \[ULN\] or bilirubin ≥ 3 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral diclofenac exposure. 12. Subject has any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject has significantly impaired renal function as evidenced by an estimated GFR of ≤60 ml/min/1.73m2. 13. Subject is considered by the investigator, for any reason (including, but not limited to the risks described as precautions, warnings, and contraindications in the Prescribing Information for Cambia), to be an unsuitable candidate to receive the study medication. 14. Subject has a history of laboratory test results obtained within 6 months before the Screening visit that show the presence of HIV, hepatitis B surface antigen, hepatitis C antibody, or active hepatitis A immunoglobulin M. 15. Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac (refer to the products' professional labeling) or the subject has not undergone a washout period of at least 5-6 half-lives of PK or PD, whichever is longer, for these medications. 16. Subject has a known or suspected history of alcohol use and or drug/ substance abuse or misuse within 2 years before Screening; or evidence of tolerance or physical dependence before study medication administration. 17. Subject has a documented history of a medical condition that, in the opinion of the investigator, would compromise the subject's ability to absorb, metabolize, or excrete diclofenac, including (but not limited to) intractable nausea and/or vomiting and/or severe GI narrowing (pathologic or iatrogenic). 18. Subject has received any investigational product or device within 30 days before the Screening, or is scheduled to receive an investigational device or another investigational drug (other than Cambia) during the course of this study. 19. Subject is a relative of a member of the study site staff or Sponsor directly involved in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Outcome (1 of 6) | 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose) | • Cmax: maximum concentration (ng/mL) |
| Pharmacokinetics Outcome (2 of 6) | 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose) | • tmax: time to maximum concentration (min) |
| Pharmacokinetics Outcome (3 of 6) | 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose) | • λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min) |
| Pharmacokinetics Outcome (4 of 6) | 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose) | • t1/2: terminal elimination half-life (min) |
| Pharmacokinetics Outcome (5 of 6) | 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose) | • AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min\*ng/mL) |
| Pharmacokinetics Outcome (6 of 6) | 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose) | • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min\*ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome (5.3 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in vital sign measurements: Respiratory Rate (breaths/min). |
| Safety Outcome (5.4 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in vital sign measurements: Systolic Blood Pressure (mmHg). |
| Safety Outcome (5.5 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg). |
| Safety Outcome (6.1 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Hematocrit (L/L). |
| Safety Outcome (6.2 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L). |
| Safety Outcome (6.3 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Platelet Count (Cells \* 10\^9/L). |
| Safety Outcome (6.4 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - White Blood Cells (Cells \* 10\^9/L). |
| Safety Outcome (6.5 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Basophils (%). |
| Safety Outcome (6.6 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Eosinophils (%). |
| Safety Outcome (6.7 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Neutrophils (%). |
| Safety Outcome (6.8 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Lymphocytes (%). |
| Safety Outcome (6.9 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Hematology - Monocytes (%). |
| Safety Outcome (6.10 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Albumin (g/L). |
| Safety Outcome (6.11 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L). |
| Safety Outcome (1 of 7) | 3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken) | • Treatment emergent AEs (TEAEs) |
| Safety Outcome (6.13 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L). |
| Safety Outcome (6.14 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L). |
| Safety Outcome (6.15 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L). |
| Safety Outcome (6.16 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L). |
| Safety Outcome (6.17 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L). |
| Safety Outcome (6.18 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L). |
| Safety Outcome (6.19 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L). |
| Safety Outcome (6.20 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - LDH (U/L). |
| Safety Outcome (6.21 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L). |
| Safety Outcome (6.22 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L). |
| Safety Outcome (6.23 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Urinalysis - pH. |
| Safety Outcome (6.24 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Urinalysis - Specific Gravity. |
| Safety Outcome (7 of 7) | 3 months (signed informed consent/assent to the final visit) | • Physical examination findings including abnormal clinically significant findings |
| Safety Outcome (6.12 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L). |
| Safety Outcome (2 of 7) | 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken) | • Serious adverse events (SAEs) |
| Safety Outcome (3 of 7) | 3 months (signed informed consent/assent to 30 days after the last dose of study medication taken) | • Withdrawals due to AEs |
| Safety Outcome (4 of 7) | 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken) | • Deaths |
| Safety Outcome (5.1 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in vital sign measurements: Temperature (degrees C). |
| Safety Outcome (5.2 of 7) | 3 months (signed informed consent/assent to the final visit) | • Changes in vital sign measurements: Heart Rate (beats/min). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cambia® Diclofenac Potassium for Oral Solution (NSAID), 50 mg | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Cambia® |
|---|---|
| Age, Continuous | 15.5 years STANDARD_DEVIATION 1.66 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Pharmacokinetics Outcome (1 of 6)
• Cmax: maximum concentration (ng/mL)
Time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Population: The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 6 hrs post-dose concentrations (ng/mL) | 14.26 ng/mL | Standard Deviation 7.507 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | Cmax (ng/mL) | 1411.96 ng/mL | Standard Deviation 846.208 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | pre-dose concentrations (ng/mL) | 0.00 ng/mL | Standard Deviation 0 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 5 min post-dose concentrations (ng/mL) | 649.78 ng/mL | Standard Deviation 1008.783 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 10 min post-dose concentrations (ng/mL) | 1123.88 ng/mL | Standard Deviation 881.619 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 15 min post-dose concentrations (ng/mL) | 1247.72 ng/mL | Standard Deviation 824.194 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 20 min post-dose concentrations (ng/mL) | 1084.52 ng/mL | Standard Deviation 575.825 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 30 min post-dose concentrations (ng/mL) | 855.92 ng/mL | Standard Deviation 469.835 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 40 min post-dose concentrations (ng/mL) | 629.96 ng/mL | Standard Deviation 295.361 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 60 min post-dose concentrations (ng/mL) | 535.44 ng/mL | Standard Deviation 295.222 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 2 hrs post-dose concentrations (ng/mL) | 164.25 ng/mL | Standard Deviation 107.706 |
| Cambia® | Pharmacokinetics Outcome (1 of 6) | 4 hrs post-dose concentrations (ng/mL) | 40.20 ng/mL | Standard Deviation 25.285 |
Primary
Pharmacokinetics Outcome (2 of 6)
• tmax: time to maximum concentration (min)
Time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Population: The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cambia® | Pharmacokinetics Outcome (2 of 6) | 18.00 min | Standard Deviation 11.551 |
Primary
Pharmacokinetics Outcome (3 of 6)
• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)
Time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Population: The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cambia® | Pharmacokinetics Outcome (3 of 6) | 0.01 1/min | Standard Deviation 0.002 |
Primary
Pharmacokinetics Outcome (4 of 6)
• t1/2: terminal elimination half-life (min)
Time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Population: The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cambia® | Pharmacokinetics Outcome (4 of 6) | 66.79 min | Standard Deviation 9.193 |
Primary
Pharmacokinetics Outcome (5 of 6)
• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min\*ng/mL)
Time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Population: The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cambia® | Pharmacokinetics Outcome (5 of 6) | 82920.03 min*ng/mL | Standard Deviation 25327.634 |
Primary
Pharmacokinetics Outcome (6 of 6)
• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min\*ng/mL)
Time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
Population: The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cambia® | Pharmacokinetics Outcome (6 of 6) | 84388.75 min*ng/mL | Standard Deviation 25993.623 |
Secondary
Safety Outcome (1 of 7)
• Treatment emergent AEs (TEAEs)
Time frame: 3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cambia® | Safety Outcome (1 of 7) | 10 Participants |
Secondary
Safety Outcome (2 of 7)
• Serious adverse events (SAEs)
Time frame: 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cambia® | Safety Outcome (2 of 7) | 1 Participants |
Secondary
Safety Outcome (3 of 7)
• Withdrawals due to AEs
Time frame: 3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cambia® | Safety Outcome (3 of 7) | 0 Participants |
Secondary
Safety Outcome (4 of 7)
• Deaths
Time frame: 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cambia® | Safety Outcome (4 of 7) | 0 Participants |
Secondary
Safety Outcome (5.1 of 7)
• Changes in vital sign measurements: Temperature (degrees C).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (5.1 of 7) | Baseline (degrees C) | 36.52 degrees C | Standard Deviation 0.569 |
| Cambia® | Safety Outcome (5.1 of 7) | Final Visit (degrees C) | 36.72 degrees C | Standard Deviation 0.499 |
| Cambia® | Safety Outcome (5.1 of 7) | Change from Baseline to Final Visit (degrees C) | 0.20 degrees C | Standard Deviation 0.491 |
Secondary
Safety Outcome (5.2 of 7)
• Changes in vital sign measurements: Heart Rate (beats/min).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (5.2 of 7) | Baseline (beats/min) | 74.6 beats/min | Standard Deviation 12.41 |
| Cambia® | Safety Outcome (5.2 of 7) | Final Visit (beats/min) | 74.7 beats/min | Standard Deviation 9.23 |
| Cambia® | Safety Outcome (5.2 of 7) | Change from Baseline to Final Visit (beats/min) | 0.2 beats/min | Standard Deviation 10.95 |
Secondary
Safety Outcome (5.3 of 7)
• Changes in vital sign measurements: Respiratory Rate (breaths/min).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (5.3 of 7) | Baseline (breaths/min) | 15.4 breaths/min | Standard Deviation 1.23 |
| Cambia® | Safety Outcome (5.3 of 7) | Final Visit (breaths/min) | 15.6 breaths/min | Standard Deviation 0.82 |
| Cambia® | Safety Outcome (5.3 of 7) | Change from Baseline to Final Visit (breaths/min) | 0.1 breaths/min | Standard Deviation 1.42 |
Secondary
Safety Outcome (5.4 of 7)
• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (5.4 of 7) | Final Visit (mm Hg) | 109.6 mm Hg | Standard Deviation 9.83 |
| Cambia® | Safety Outcome (5.4 of 7) | Change from Baseline to Final Visit (mm Hg) | -3.1 mm Hg | Standard Deviation 14.27 |
| Cambia® | Safety Outcome (5.4 of 7) | Baseline (mm Hg) | 112.7 mm Hg | Standard Deviation 11.71 |
Secondary
Safety Outcome (5.5 of 7)
• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (5.5 of 7) | Baseline (mm Hg) | 68.8 mm Hg | Standard Deviation 8.78 |
| Cambia® | Safety Outcome (5.5 of 7) | Final Visit (mm Hg) | 67.1 mm Hg | Standard Deviation 7.07 |
| Cambia® | Safety Outcome (5.5 of 7) | Change from Baseline to Final Visit (mm Hg) | -1.7 mm Hg | Standard Deviation 9.62 |
Secondary
Safety Outcome (6.10 of 7)
• Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.10 of 7) | Baseline (g/L) | 43.800 g/L | Standard Deviation 4.0415 |
| Cambia® | Safety Outcome (6.10 of 7) | Final Visit (g/L) | 47.200 g/L | Standard Deviation 4.4441 |
| Cambia® | Safety Outcome (6.10 of 7) | Change from Baseline to Final Visit (g/L) | 3.400 g/L | Standard Deviation 3.0277 |
Secondary
Safety Outcome (6.11 of 7)
• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.11 of 7) | Baseline (U/L) | 98.960 U/L | Standard Deviation 85.0022 |
| Cambia® | Safety Outcome (6.11 of 7) | Final Visit (U/L) | 103.760 U/L | Standard Deviation 89.5378 |
| Cambia® | Safety Outcome (6.11 of 7) | Change from Baseline to Final Visit (U/L) | 4.800 U/L | Standard Deviation 11.4054 |
Secondary
Safety Outcome (6.12 of 7)
• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.12 of 7) | Baseline (U/L) | 12.680 U/L | Standard Deviation 5.7134 |
| Cambia® | Safety Outcome (6.12 of 7) | Final Visit (U/L) | 13.080 U/L | Standard Deviation 5.1553 |
| Cambia® | Safety Outcome (6.12 of 7) | Change from Baseline to Final Visit (U/L) | 0.400 U/L | Standard Deviation 2.0817 |
Secondary
Safety Outcome (6.13 of 7)
• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.13 of 7) | Baseline (U/L) | 17.240 U/L | Standard Deviation 4.576 |
| Cambia® | Safety Outcome (6.13 of 7) | Final Visit (U/L) | 18.040 U/L | Standard Deviation 4.6947 |
| Cambia® | Safety Outcome (6.13 of 7) | Change from Baseline to Final Visit (U/L) | 0.800 U/L | Standard Deviation 2.6615 |
Secondary
Safety Outcome (6.14 of 7)
• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.14 of 7) | Baseline (mmol/L) | 23.400 mmol/L | Standard Deviation 1.8028 |
| Cambia® | Safety Outcome (6.14 of 7) | Final Visit (mmol/L) | 23.920 mmol/L | Standard Deviation 2.197 |
| Cambia® | Safety Outcome (6.14 of 7) | Change from Baseline to Final Visit (mmol/L) | 0.520 mmol/L | Standard Deviation 2.7099 |
Secondary
Safety Outcome (6.15 of 7)
• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.15 of 7) | Baseline (umol/L) | 9.029 umol/L | Standard Deviation 4.1454 |
| Cambia® | Safety Outcome (6.15 of 7) | Final Visit (umol/L) | 10.192 umol/L | Standard Deviation 5.5311 |
| Cambia® | Safety Outcome (6.15 of 7) | Change from Baseline to Final Visit (umol/L) | 1.163 umol/L | Standard Deviation 3.9107 |
Secondary
Safety Outcome (6.16 of 7)
• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.16 of 7) | Baseline (mmol/L) | 4.512 mmol/L | Standard Deviation 1.0858 |
| Cambia® | Safety Outcome (6.16 of 7) | Final Visit (mmol/L) | 4.594 mmol/L | Standard Deviation 1.2965 |
| Cambia® | Safety Outcome (6.16 of 7) | Change from Baseline to Final Visit (mmol/L) | 0.081 mmol/L | Standard Deviation 1.0515 |
Secondary
Safety Outcome (6.17 of 7)
• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.17 of 7) | Baseline (mmol/L) | 105.480 mmol/L | Standard Deviation 1.9604 |
| Cambia® | Safety Outcome (6.17 of 7) | Final Visit (mmol/L) | 104.880 mmol/L | Standard Deviation 2.7435 |
| Cambia® | Safety Outcome (6.17 of 7) | Change from Baseline to Final Visit (mmol/L) | -0.600 mmol/L | Standard Deviation 2.1602 |
Secondary
Safety Outcome (6.18 of 7)
• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.18 of 7) | Baseline (umol/L) | 66.760 umol/L | Standard Deviation 11.2603 |
| Cambia® | Safety Outcome (6.18 of 7) | Final Visit (umol/L) | 67.467 umol/L | Standard Deviation 10.7228 |
| Cambia® | Safety Outcome (6.18 of 7) | Change from Baseline to Final Visit (umol/L) | 0.707 umol/L | Standard Deviation 8.1866 |
Secondary
Safety Outcome (6.19 of 7)
• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.19 of 7) | Baseline (mmol/L) | 4.758 mmol/L | Standard Deviation 0.6037 |
| Cambia® | Safety Outcome (6.19 of 7) | Final Visit (mmol/L) | 4.483 mmol/L | Standard Deviation 0.859 |
| Cambia® | Safety Outcome (6.19 of 7) | Change from Baseline to Final Visit (mmol/L) | -0.275 mmol/L | Standard Deviation 0.9215 |
Secondary
Safety Outcome (6.1 of 7)
• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.1 of 7) | Baseline (L/L) | 0.388 L/L | Standard Deviation 0.0329 |
| Cambia® | Safety Outcome (6.1 of 7) | Final Visit (L/L) | 0.408 L/L | Standard Deviation 0.0344 |
| Cambia® | Safety Outcome (6.1 of 7) | Change from Baseline to Final Visit (L/L) | 0.020 L/L | Standard Deviation 0.019 |
Secondary
Safety Outcome (6.20 of 7)
• Changes in clinical laboratory results: Chemistry - LDH (U/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.20 of 7) | Baseline (U/L) | 157.882 U/L | Standard Deviation 59.0824 |
| Cambia® | Safety Outcome (6.20 of 7) | Final Visit (U/L) | 159.708 U/L | Standard Deviation 41.5425 |
| Cambia® | Safety Outcome (6.20 of 7) | Change from Baseline to Final Visit (U/L) | -0.882 U/L | Standard Deviation 74.6064 |
Secondary
Safety Outcome (6.21 of 7)
• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.21 of 7) | Baseline (mmol/L) | 3.964 mmol/L | Standard Deviation 0.2215 |
| Cambia® | Safety Outcome (6.21 of 7) | Final Visit (mmol/L) | 4.060 mmol/L | Standard Deviation 0.2784 |
| Cambia® | Safety Outcome (6.21 of 7) | Change from Baseline to Final Visit (mmol/L) | 0.096 mmol/L | Standard Deviation 0.3007 |
Secondary
Safety Outcome (6.22 of 7)
• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.22 of 7) | Baseline (mmol/L) | 138.640 mmol/L | Standard Deviation 1.036 |
| Cambia® | Safety Outcome (6.22 of 7) | Final Visit (mmol/L) | 138.840 mmol/L | Standard Deviation 1.5188 |
| Cambia® | Safety Outcome (6.22 of 7) | Change from Baseline to Final Visit (mmol/L) | 0.200 mmol/L | Standard Deviation 1.6833 |
Secondary
Safety Outcome (6.23 of 7)
• Changes in clinical laboratory results: Urinalysis - pH.
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.23 of 7) | Baseline (pH) | 6.220 pH | Standard Deviation 0.7511 |
| Cambia® | Safety Outcome (6.23 of 7) | Final Visit (pH) | 6.300 pH | Standard Deviation 0.7773 |
| Cambia® | Safety Outcome (6.23 of 7) | Change from Baseline to Final Visit (pH) | 0.080 pH | Standard Deviation 0.8977 |
Secondary
Safety Outcome (6.24 of 7)
• Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.24 of 7) | Baseline (Specific Gravity) | 1.020 Specific Gravity | Standard Deviation 0.0085 |
| Cambia® | Safety Outcome (6.24 of 7) | Final Visit (Specific Gravity) | 1.022 Specific Gravity | Standard Deviation 0.006 |
| Cambia® | Safety Outcome (6.24 of 7) | Change from Baseline to Final Visit (Spec.Gravity) | 0.002 Specific Gravity | Standard Deviation 0.0081 |
Secondary
Safety Outcome (6.2 of 7)
• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.2 of 7) | Baseline (g/L) | 128.000 g/L | Standard Deviation 11.4419 |
| Cambia® | Safety Outcome (6.2 of 7) | Final Visit (g/L) | 132.720 g/L | Standard Deviation 11.6638 |
| Cambia® | Safety Outcome (6.2 of 7) | Change from Baseline to Final Visit (g/L) | 4.720 g/L | Standard Deviation 5.443 |
Secondary
Safety Outcome (6.3 of 7)
• Changes in clinical laboratory results: Hematology - Platelet Count (Cells \* 10\^9/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.3 of 7) | Baseline (Cells * 10^9/L) | 233.640 Cells * 10^9/L | Standard Deviation 43.4855 |
| Cambia® | Safety Outcome (6.3 of 7) | Final Visit (Cells * 10^9/L) | 244.960 Cells * 10^9/L | Standard Deviation 47.0049 |
| Cambia® | Safety Outcome (6.3 of 7) | Change from Baseline to Final Visit (Cells*10^9/L) | 11.320 Cells * 10^9/L | Standard Deviation 42.3642 |
Secondary
Safety Outcome (6.4 of 7)
• Changes in clinical laboratory results: Hematology - White Blood Cells (Cells \* 10\^9/L).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.4 of 7) | Baseline (Cells * 10^9/L) | 6.512 Cells * 10^9/L | Standard Deviation 1.9935 |
| Cambia® | Safety Outcome (6.4 of 7) | Final Visit (Cells * 10^9/L) | 6.262 Cells * 10^9/L | Standard Deviation 1.4957 |
| Cambia® | Safety Outcome (6.4 of 7) | Change from Baseline to Final Visit (Cells*10^9/L) | -0.249 Cells * 10^9/L | Standard Deviation 2.0634 |
Secondary
Safety Outcome (6.5 of 7)
• Changes in clinical laboratory results: Hematology - Basophils (%).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.5 of 7) | Change from Baseline to Final Visit (% Basophils) | 0.026 % Basophils | Standard Deviation 0.519 |
| Cambia® | Safety Outcome (6.5 of 7) | Baseline (% Basophils) | 0.324 % Basophils | Standard Deviation 0.3829 |
| Cambia® | Safety Outcome (6.5 of 7) | Final Visit (% Basophils) | 0.350 % Basophils | Standard Deviation 0.3766 |
Secondary
Safety Outcome (6.6 of 7)
• Changes in clinical laboratory results: Hematology - Eosinophils (%).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.6 of 7) | Baseline (% Eosinophils) | 2.730 % Eosinophils | Standard Deviation 2.0728 |
| Cambia® | Safety Outcome (6.6 of 7) | Final Visit (% Eosinophils) | 2.036 % Eosinophils | Standard Deviation 1.6519 |
| Cambia® | Safety Outcome (6.6 of 7) | Change from Baseline to Final Visit(% Eosinophils) | -0.694 % Eosinophils | Standard Deviation 1.7186 |
Secondary
Safety Outcome (6.7 of 7)
• Changes in clinical laboratory results: Hematology - Neutrophils (%).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.7 of 7) | Baseline (% Neutrophils) | 54.530 % Neutrophils | Standard Deviation 9.7221 |
| Cambia® | Safety Outcome (6.7 of 7) | Final Visit (% Neutrophils) | 57.932 % Neutrophils | Standard Deviation 8.4095 |
| Cambia® | Safety Outcome (6.7 of 7) | Change from Baseline to Final Visit(% Neutrophils) | 3.402 % Neutrophils | Standard Deviation 10.1083 |
Secondary
Safety Outcome (6.8 of 7)
• Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.8 of 7) | Baseline (% Lymphocytes) | 36.260 % Lymphocytes | Standard Deviation 8.9981 |
| Cambia® | Safety Outcome (6.8 of 7) | Final Visit (% Lymphocytes) | 33.745 % Lymphocytes | Standard Deviation 7.526 |
| Cambia® | Safety Outcome (6.8 of 7) | Change from Baseline to Final Visit(% Lymphocytes) | -2.515 % Lymphocytes | Standard Deviation 9.1165 |
Secondary
Safety Outcome (6.9 of 7)
• Changes in clinical laboratory results: Hematology - Monocytes (%).
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cambia® | Safety Outcome (6.9 of 7) | Baseline (% Monocytes) | 6.030 % Monocytes | Standard Deviation 1.8765 |
| Cambia® | Safety Outcome (6.9 of 7) | Final Visit (% Monocytes) | 5.847 % Monocytes | Standard Deviation 1.717 |
| Cambia® | Safety Outcome (6.9 of 7) | Change from Baseline to Final Visit (% Monocytes) | -0.183 % Monocytes | Standard Deviation 1.7852 |
Secondary
Safety Outcome (7 of 7)
• Physical examination findings including abnormal clinically significant findings
Time frame: 3 months (signed informed consent/assent to the final visit)
Population: The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented is a clinically significant change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cambia® | Safety Outcome (7 of 7) | 1 Participants |