Trial Outcomes & Findings for Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds (NCT NCT02287376)
NCT ID: NCT02287376
Last Updated: 2017-07-25
Results Overview
• Cmax: maximum concentration (ng/mL)
COMPLETED
PHASE4
25 participants
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
2017-07-25
Participant Flow
Participant milestones
| Measure |
Cambia®
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds
Baseline characteristics by cohort
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 1.66 • n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
• Cmax: maximum concentration (ng/mL)
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Pharmacokinetics Outcome (1 of 6)
Cmax (ng/mL)
|
1411.96 ng/mL
Standard Deviation 846.208
|
|
Pharmacokinetics Outcome (1 of 6)
pre-dose concentrations (ng/mL)
|
0.00 ng/mL
Standard Deviation 0.000
|
|
Pharmacokinetics Outcome (1 of 6)
5 min post-dose concentrations (ng/mL)
|
649.78 ng/mL
Standard Deviation 1008.783
|
|
Pharmacokinetics Outcome (1 of 6)
10 min post-dose concentrations (ng/mL)
|
1123.88 ng/mL
Standard Deviation 881.619
|
|
Pharmacokinetics Outcome (1 of 6)
15 min post-dose concentrations (ng/mL)
|
1247.72 ng/mL
Standard Deviation 824.194
|
|
Pharmacokinetics Outcome (1 of 6)
20 min post-dose concentrations (ng/mL)
|
1084.52 ng/mL
Standard Deviation 575.825
|
|
Pharmacokinetics Outcome (1 of 6)
30 min post-dose concentrations (ng/mL)
|
855.92 ng/mL
Standard Deviation 469.835
|
|
Pharmacokinetics Outcome (1 of 6)
40 min post-dose concentrations (ng/mL)
|
629.96 ng/mL
Standard Deviation 295.361
|
|
Pharmacokinetics Outcome (1 of 6)
60 min post-dose concentrations (ng/mL)
|
535.44 ng/mL
Standard Deviation 295.222
|
|
Pharmacokinetics Outcome (1 of 6)
2 hrs post-dose concentrations (ng/mL)
|
164.25 ng/mL
Standard Deviation 107.706
|
|
Pharmacokinetics Outcome (1 of 6)
4 hrs post-dose concentrations (ng/mL)
|
40.20 ng/mL
Standard Deviation 25.285
|
|
Pharmacokinetics Outcome (1 of 6)
6 hrs post-dose concentrations (ng/mL)
|
14.26 ng/mL
Standard Deviation 7.507
|
PRIMARY outcome
Timeframe: 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.
• tmax: time to maximum concentration (min)
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Pharmacokinetics Outcome (2 of 6)
|
18.00 min
Standard Deviation 11.551
|
PRIMARY outcome
Timeframe: 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.
• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)
Outcome measures
| Measure |
Cambia®
n=24 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Pharmacokinetics Outcome (3 of 6)
|
0.01 1/min
Standard Deviation 0.002
|
PRIMARY outcome
Timeframe: 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.
• t1/2: terminal elimination half-life (min)
Outcome measures
| Measure |
Cambia®
n=24 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Pharmacokinetics Outcome (4 of 6)
|
66.79 min
Standard Deviation 9.193
|
PRIMARY outcome
Timeframe: 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.
• 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)
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Pharmacokinetics Outcome (5 of 6)
|
82920.03 min*ng/mL
Standard Deviation 25327.634
|
PRIMARY outcome
Timeframe: 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.
• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min\*ng/mL)
Outcome measures
| Measure |
Cambia®
n=24 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Pharmacokinetics Outcome (6 of 6)
|
84388.75 min*ng/mL
Standard Deviation 25993.623
|
SECONDARY outcome
Timeframe: 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.
• Treatment emergent AEs (TEAEs)
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (1 of 7)
|
10 Participants
|
SECONDARY outcome
Timeframe: 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.
• Serious adverse events (SAEs)
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (2 of 7)
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
• Withdrawals due to AEs
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (3 of 7)
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
• Deaths
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (4 of 7)
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
• Changes in vital sign measurements: Temperature (degrees C).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (5.1 of 7)
Baseline (degrees C)
|
36.52 degrees C
Standard Deviation 0.569
|
|
Safety Outcome (5.1 of 7)
Final Visit (degrees C)
|
36.72 degrees C
Standard Deviation 0.499
|
|
Safety Outcome (5.1 of 7)
Change from Baseline to Final Visit (degrees C)
|
0.20 degrees C
Standard Deviation 0.491
|
SECONDARY outcome
Timeframe: 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.
• Changes in vital sign measurements: Heart Rate (beats/min).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (5.2 of 7)
Baseline (beats/min)
|
74.6 beats/min
Standard Deviation 12.41
|
|
Safety Outcome (5.2 of 7)
Final Visit (beats/min)
|
74.7 beats/min
Standard Deviation 9.23
|
|
Safety Outcome (5.2 of 7)
Change from Baseline to Final Visit (beats/min)
|
0.2 beats/min
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: 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.
• Changes in vital sign measurements: Respiratory Rate (breaths/min).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (5.3 of 7)
Baseline (breaths/min)
|
15.4 breaths/min
Standard Deviation 1.23
|
|
Safety Outcome (5.3 of 7)
Final Visit (breaths/min)
|
15.6 breaths/min
Standard Deviation 0.82
|
|
Safety Outcome (5.3 of 7)
Change from Baseline to Final Visit (breaths/min)
|
0.1 breaths/min
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 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.
• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (5.4 of 7)
Baseline (mm Hg)
|
112.7 mm Hg
Standard Deviation 11.71
|
|
Safety Outcome (5.4 of 7)
Final Visit (mm Hg)
|
109.6 mm Hg
Standard Deviation 9.83
|
|
Safety Outcome (5.4 of 7)
Change from Baseline to Final Visit (mm Hg)
|
-3.1 mm Hg
Standard Deviation 14.27
|
SECONDARY outcome
Timeframe: 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.
• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (5.5 of 7)
Baseline (mm Hg)
|
68.8 mm Hg
Standard Deviation 8.78
|
|
Safety Outcome (5.5 of 7)
Final Visit (mm Hg)
|
67.1 mm Hg
Standard Deviation 7.07
|
|
Safety Outcome (5.5 of 7)
Change from Baseline to Final Visit (mm Hg)
|
-1.7 mm Hg
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.1 of 7)
Baseline (L/L)
|
0.388 L/L
Standard Deviation 0.0329
|
|
Safety Outcome (6.1 of 7)
Final Visit (L/L)
|
0.408 L/L
Standard Deviation 0.0344
|
|
Safety Outcome (6.1 of 7)
Change from Baseline to Final Visit (L/L)
|
0.020 L/L
Standard Deviation 0.0190
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.2 of 7)
Baseline (g/L)
|
128.000 g/L
Standard Deviation 11.4419
|
|
Safety Outcome (6.2 of 7)
Final Visit (g/L)
|
132.720 g/L
Standard Deviation 11.6638
|
|
Safety Outcome (6.2 of 7)
Change from Baseline to Final Visit (g/L)
|
4.720 g/L
Standard Deviation 5.4430
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Platelet Count (Cells \* 10\^9/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.3 of 7)
Baseline (Cells * 10^9/L)
|
233.640 Cells * 10^9/L
Standard Deviation 43.4855
|
|
Safety Outcome (6.3 of 7)
Final Visit (Cells * 10^9/L)
|
244.960 Cells * 10^9/L
Standard Deviation 47.0049
|
|
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 outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - White Blood Cells (Cells \* 10\^9/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.4 of 7)
Baseline (Cells * 10^9/L)
|
6.512 Cells * 10^9/L
Standard Deviation 1.9935
|
|
Safety Outcome (6.4 of 7)
Final Visit (Cells * 10^9/L)
|
6.262 Cells * 10^9/L
Standard Deviation 1.4957
|
|
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 outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Basophils (%).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.5 of 7)
Baseline (% Basophils)
|
0.324 % Basophils
Standard Deviation 0.3829
|
|
Safety Outcome (6.5 of 7)
Final Visit (% Basophils)
|
0.350 % Basophils
Standard Deviation 0.3766
|
|
Safety Outcome (6.5 of 7)
Change from Baseline to Final Visit (% Basophils)
|
0.026 % Basophils
Standard Deviation 0.5190
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Eosinophils (%).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.6 of 7)
Baseline (% Eosinophils)
|
2.730 % Eosinophils
Standard Deviation 2.0728
|
|
Safety Outcome (6.6 of 7)
Final Visit (% Eosinophils)
|
2.036 % Eosinophils
Standard Deviation 1.6519
|
|
Safety Outcome (6.6 of 7)
Change from Baseline to Final Visit(% Eosinophils)
|
-0.694 % Eosinophils
Standard Deviation 1.7186
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Neutrophils (%).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.7 of 7)
Baseline (% Neutrophils)
|
54.530 % Neutrophils
Standard Deviation 9.7221
|
|
Safety Outcome (6.7 of 7)
Final Visit (% Neutrophils)
|
57.932 % Neutrophils
Standard Deviation 8.4095
|
|
Safety Outcome (6.7 of 7)
Change from Baseline to Final Visit(% Neutrophils)
|
3.402 % Neutrophils
Standard Deviation 10.1083
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.8 of 7)
Baseline (% Lymphocytes)
|
36.260 % Lymphocytes
Standard Deviation 8.9981
|
|
Safety Outcome (6.8 of 7)
Final Visit (% Lymphocytes)
|
33.745 % Lymphocytes
Standard Deviation 7.5260
|
|
Safety Outcome (6.8 of 7)
Change from Baseline to Final Visit(% Lymphocytes)
|
-2.515 % Lymphocytes
Standard Deviation 9.1165
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Hematology - Monocytes (%).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.9 of 7)
Baseline (% Monocytes)
|
6.030 % Monocytes
Standard Deviation 1.8765
|
|
Safety Outcome (6.9 of 7)
Final Visit (% Monocytes)
|
5.847 % Monocytes
Standard Deviation 1.7170
|
|
Safety Outcome (6.9 of 7)
Change from Baseline to Final Visit (% Monocytes)
|
-0.183 % Monocytes
Standard Deviation 1.7852
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.10 of 7)
Baseline (g/L)
|
43.800 g/L
Standard Deviation 4.0415
|
|
Safety Outcome (6.10 of 7)
Final Visit (g/L)
|
47.200 g/L
Standard Deviation 4.4441
|
|
Safety Outcome (6.10 of 7)
Change from Baseline to Final Visit (g/L)
|
3.400 g/L
Standard Deviation 3.0277
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.11 of 7)
Baseline (U/L)
|
98.960 U/L
Standard Deviation 85.0022
|
|
Safety Outcome (6.11 of 7)
Final Visit (U/L)
|
103.760 U/L
Standard Deviation 89.5378
|
|
Safety Outcome (6.11 of 7)
Change from Baseline to Final Visit (U/L)
|
4.800 U/L
Standard Deviation 11.4054
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.12 of 7)
Baseline (U/L)
|
12.680 U/L
Standard Deviation 5.7134
|
|
Safety Outcome (6.12 of 7)
Final Visit (U/L)
|
13.080 U/L
Standard Deviation 5.1553
|
|
Safety Outcome (6.12 of 7)
Change from Baseline to Final Visit (U/L)
|
0.400 U/L
Standard Deviation 2.0817
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.13 of 7)
Baseline (U/L)
|
17.240 U/L
Standard Deviation 4.5760
|
|
Safety Outcome (6.13 of 7)
Final Visit (U/L)
|
18.040 U/L
Standard Deviation 4.6947
|
|
Safety Outcome (6.13 of 7)
Change from Baseline to Final Visit (U/L)
|
0.800 U/L
Standard Deviation 2.6615
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.14 of 7)
Baseline (mmol/L)
|
23.400 mmol/L
Standard Deviation 1.8028
|
|
Safety Outcome (6.14 of 7)
Final Visit (mmol/L)
|
23.920 mmol/L
Standard Deviation 2.1970
|
|
Safety Outcome (6.14 of 7)
Change from Baseline to Final Visit (mmol/L)
|
0.520 mmol/L
Standard Deviation 2.7099
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.15 of 7)
Baseline (umol/L)
|
9.029 umol/L
Standard Deviation 4.1454
|
|
Safety Outcome (6.15 of 7)
Final Visit (umol/L)
|
10.192 umol/L
Standard Deviation 5.5311
|
|
Safety Outcome (6.15 of 7)
Change from Baseline to Final Visit (umol/L)
|
1.163 umol/L
Standard Deviation 3.9107
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.16 of 7)
Baseline (mmol/L)
|
4.512 mmol/L
Standard Deviation 1.0858
|
|
Safety Outcome (6.16 of 7)
Final Visit (mmol/L)
|
4.594 mmol/L
Standard Deviation 1.2965
|
|
Safety Outcome (6.16 of 7)
Change from Baseline to Final Visit (mmol/L)
|
0.081 mmol/L
Standard Deviation 1.0515
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.17 of 7)
Baseline (mmol/L)
|
105.480 mmol/L
Standard Deviation 1.9604
|
|
Safety Outcome (6.17 of 7)
Final Visit (mmol/L)
|
104.880 mmol/L
Standard Deviation 2.7435
|
|
Safety Outcome (6.17 of 7)
Change from Baseline to Final Visit (mmol/L)
|
-0.600 mmol/L
Standard Deviation 2.1602
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.18 of 7)
Baseline (umol/L)
|
66.760 umol/L
Standard Deviation 11.2603
|
|
Safety Outcome (6.18 of 7)
Final Visit (umol/L)
|
67.467 umol/L
Standard Deviation 10.7228
|
|
Safety Outcome (6.18 of 7)
Change from Baseline to Final Visit (umol/L)
|
0.707 umol/L
Standard Deviation 8.1866
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.19 of 7)
Baseline (mmol/L)
|
4.758 mmol/L
Standard Deviation 0.6037
|
|
Safety Outcome (6.19 of 7)
Final Visit (mmol/L)
|
4.483 mmol/L
Standard Deviation 0.8590
|
|
Safety Outcome (6.19 of 7)
Change from Baseline to Final Visit (mmol/L)
|
-0.275 mmol/L
Standard Deviation 0.9215
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - LDH (U/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.20 of 7)
Baseline (U/L)
|
157.882 U/L
Standard Deviation 59.0824
|
|
Safety Outcome (6.20 of 7)
Final Visit (U/L)
|
159.708 U/L
Standard Deviation 41.5425
|
|
Safety Outcome (6.20 of 7)
Change from Baseline to Final Visit (U/L)
|
-0.882 U/L
Standard Deviation 74.6064
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.21 of 7)
Baseline (mmol/L)
|
3.964 mmol/L
Standard Deviation 0.2215
|
|
Safety Outcome (6.21 of 7)
Final Visit (mmol/L)
|
4.060 mmol/L
Standard Deviation 0.2784
|
|
Safety Outcome (6.21 of 7)
Change from Baseline to Final Visit (mmol/L)
|
0.096 mmol/L
Standard Deviation 0.3007
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.22 of 7)
Baseline (mmol/L)
|
138.640 mmol/L
Standard Deviation 1.0360
|
|
Safety Outcome (6.22 of 7)
Final Visit (mmol/L)
|
138.840 mmol/L
Standard Deviation 1.5188
|
|
Safety Outcome (6.22 of 7)
Change from Baseline to Final Visit (mmol/L)
|
0.200 mmol/L
Standard Deviation 1.6833
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Urinalysis - pH.
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.23 of 7)
Baseline (pH)
|
6.220 pH
Standard Deviation 0.7511
|
|
Safety Outcome (6.23 of 7)
Final Visit (pH)
|
6.300 pH
Standard Deviation 0.7773
|
|
Safety Outcome (6.23 of 7)
Change from Baseline to Final Visit (pH)
|
0.080 pH
Standard Deviation 0.8977
|
SECONDARY outcome
Timeframe: 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.
• Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (6.24 of 7)
Baseline (Specific Gravity)
|
1.020 Specific Gravity
Standard Deviation 0.0085
|
|
Safety Outcome (6.24 of 7)
Final Visit (Specific Gravity)
|
1.022 Specific Gravity
Standard Deviation 0.0060
|
|
Safety Outcome (6.24 of 7)
Change from Baseline to Final Visit (Spec.Gravity)
|
0.002 Specific Gravity
Standard Deviation 0.0081
|
SECONDARY outcome
Timeframe: 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.
• Physical examination findings including abnormal clinically significant findings
Outcome measures
| Measure |
Cambia®
n=25 Participants
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Safety Outcome (7 of 7)
|
1 Participants
|
Adverse Events
Cambia®
Serious adverse events
| Measure |
Cambia®
n=25 participants at risk
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.0%
1/25 • 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
The Safety population included all subjects who have received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
4.0%
1/25 • 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
The Safety population included all subjects who have received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Cambia®
n=25 participants at risk
Diclofenac Potassium for Oral Solution (NSAID), 50 mg
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
The Safety population included all subjects who have received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Motion Sickness
|
8.0%
2/25 • 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
The Safety population included all subjects who have received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
- Publication restrictions are in place
Restriction type: OTHER