Trial Outcomes & Findings for Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain (NCT NCT02287350)
NCT ID: NCT02287350
Last Updated: 2017-07-11
Results Overview
• Cmax: maximum concentration (ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Diclofenac Potassium Oral Solution
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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|---|---|
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Overall Study
STARTED
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51
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Overall Study
COMPLETED
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48
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Baseline characteristics by cohort
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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Age, Continuous
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6.4 years
STANDARD_DEVIATION 3.10 • n=5 Participants
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Sex: Female, Male
Female
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28 Participants
n=5 Participants
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Sex: Female, Male
Male
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23 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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 |
Diclofenac Potassium Oral Solution
n=19 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
4 hrs post-dose concentrations (ng/mL)
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22.964 ng/mL
Standard Deviation 21.4744
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
6 hrs post-dose concentrations (ng/mL)
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15.042 ng/mL
Standard Deviation 13.0339
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
Cmax (ng/mL)
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433.9 ng/mL
Standard Deviation 297.53
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
pre-dose concentrations (ng/mL)
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0.000 ng/mL
Standard Deviation 0.0000
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
15 min post-dose concentrations (ng/mL)
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378.471 ng/mL
Standard Deviation 315.3756
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
30 min post-dose concentrations (ng/mL)
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260.484 ng/mL
Standard Deviation 161.9306
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
60 min post-dose concentrations (ng/mL)
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178.544 ng/mL
Standard Deviation 108.9297
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
2 hrs post-dose concentrations (ng/mL)
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67.394 ng/mL
Standard Deviation 54.5705
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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 (hr)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=18 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).
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0.250 hr
Interval 0.22 to 1.08
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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 (1/hr)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=17 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).
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0.47329 1/hr
Standard Deviation 0.141463
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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 (hr)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=17 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).
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1.692 hr
Standard Deviation 0.8811
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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 (hr\*ng/mL)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=18 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).
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454.544 hr*ng/mL
Standard Deviation 219.3114
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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 (∞) (hr\*ng/mL)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=17 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).
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491.915 hr*ng/mL
Standard Deviation 244.0359
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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.
• CL/F: apparent clearance (mL/hr).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=17 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).
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25927.177 mL/hr
Standard Deviation 12582.7293
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PRIMARY outcome
Timeframe: 6 hours (pre-dose, 15, 30, 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.
• Vz/F: apparent volume of distribution (mL).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=17 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).
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66845.275 mL
Standard Deviation 64351.3897
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SECONDARY outcome
Timeframe: 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)Population: The Safety population included all subjects who have received at least 1 dose of study drug.
• Treatment emergent AEs (TEAEs)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).
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16 Participants
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SECONDARY outcome
Timeframe: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)Population: The Safety population included all subjects who have received at least 1 dose of study drug.
• Serious adverse events (SAEs)
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).
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2 Participants
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SECONDARY outcome
Timeframe: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)Population: The Safety population included all subjects who have received at least 1 dose of study drug.
• Withdrawals due to AEs
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).
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0 Participants
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SECONDARY outcome
Timeframe: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)Population: The Safety population included all subjects who have received at least 1 dose of study drug.
• Deaths
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).
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0 Participants
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SECONDARY outcome
Timeframe: 4 weeks (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 non-missing measurement taken before first treatment with study drug.
• Changes in vital sign measurements: Temperature (degrees C).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).
Baseline (degrees C)
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36.94 degrees C
Standard Deviation 0.485
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).
Final Visit (degrees C)
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36.67 degrees C
Standard Deviation 0.492
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).
Change from Baseline to Final Visit (degrees C)
|
-0.29 degrees C
Standard Deviation 0.511
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SECONDARY outcome
Timeframe: 4 weeks (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 non-missing measurement taken before first treatment with study drug.
• Changes in vital sign measurements: Pulse Rate (beats/min).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).
Baseline (beats/min)
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103.7 beats/min
Standard Deviation 24.41
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).
Final Visit (beats/min)
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93.4 beats/min
Standard Deviation 16.61
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).
Change from Baseline to Final Visit (beats/min)
|
-10.5 beats/min
Standard Deviation 17.91
|
SECONDARY outcome
Timeframe: 4 weeks (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 non-missing measurement taken before first treatment with study drug.
• Changes in vital sign measurements: Respiratory Rate (breaths/min).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).
Baseline (breaths/min)
|
19.7 breaths/min
Standard Deviation 3.55
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).
Final Visit (breaths/min)
|
19.0 breaths/min
Standard Deviation 2.90
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).
Change from Baseline to Final Visit (breaths/min)
|
-0.9 breaths/min
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: 4 weeks (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 non-missing measurement taken before first treatment with study drug.
• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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|---|---|
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).
Final Visit (mmHg)
|
106.6 mmHg
Standard Deviation 13.08
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).
Change from Baseline to Final Visit (mmHg)
|
-4.5 mmHg
Standard Deviation 15.45
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).
Baseline (mmHg)
|
110.8 mmHg
Standard Deviation 15.29
|
SECONDARY outcome
Timeframe: 4 weeks (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 non-missing measurement taken before first treatment with study drug.
• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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|---|---|
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).
Baseline (mmHg)
|
70.1 mmHg
Standard Deviation 12.39
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).
Final Visit (mmHg)
|
65.1 mmHg
Standard Deviation 10.86
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).
Change from Baseline to Final Visit (mmHg)
|
-5.2 mmHg
Standard Deviation 13.81
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
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|---|---|
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To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).
Baseline (L/L)
|
0.357 L/L
Standard Deviation 0.0264
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).
Final Visit (L/L)
|
0.363 L/L
Standard Deviation 0.0290
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).
Change from Baseline to Final Visit (L/L)
|
0.006 L/L
Standard Deviation 0.0269
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).
Baseline (g/L)
|
120.5 g/L
Standard Deviation 10.55
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).
Final Visit (g/L)
|
121.0 g/L
Standard Deviation 10.69
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).
Change from Baseline to Final Visit (g/L)
|
0.4 g/L
Standard Deviation 8.20
|
SECONDARY outcome
Timeframe: 4 weeks (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 (10\^9/L).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).
Baseline (10^9/L)
|
315.2 10^9/L
Standard Deviation 62.79
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).
Final Visit (10^9/L)
|
402.2 10^9/L
Standard Deviation 109.11
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).
Change from Baseline to Final Visit (10^9/L)
|
85.6 10^9/L
Standard Deviation 112.28
|
SECONDARY outcome
Timeframe: 4 weeks (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 (10\^9/L).
Outcome measures
| Measure |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).
Baseline (10^9/L)
|
8.749 10^9/L
Standard Deviation 4.7523
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).
Final Visit (10^9/L)
|
8.807 10^9/L
Standard Deviation 2.2423
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).
Change from Baseline to Final Visit (10^9/L)
|
-0.054 10^9/L
Standard Deviation 4.7766
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).
Baseline (% Basophils)
|
0.414 % Basophils
Standard Deviation 0.3068
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).
Final Visit (% Basophils)
|
0.496 % Basophils
Standard Deviation 0.3150
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).
Change from Baseline to Final Visit (% Basophils)
|
0.085 % Basophils
Standard Deviation 0.2466
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).
Baseline (% Eosinophils)
|
3.911 % Eosinophils
Standard Deviation 3.2009
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).
Final Visit (% Eosinophils)
|
4.514 % Eosinophils
Standard Deviation 3.1678
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).
Change from Baseline to Final Visit(% Eosinophils)
|
0.532 % Eosinophils
Standard Deviation 2.9069
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).
Baseline (% Neutrophils)
|
49.649 % Neutrophils
Standard Deviation 15.1446
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).
Final Visit (% Neutrophils)
|
48.740 % Neutrophils
Standard Deviation 11.1360
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).
Change from Baseline to Final Visit(% Neutrophils)
|
-0.791 % Neutrophils
Standard Deviation 17.9732
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).
Final Visit (% Lymphocytes)
|
38.186 % Lymphocytes
Standard Deviation 10.4428
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).
Baseline (% Lymphocytes)
|
37.195 % Lymphocytes
Standard Deviation 12.4809
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).
Change from Baseline to Final Visit(% Lymphocytes)
|
0.866 % Lymphocytes
Standard Deviation 16.2141
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).
Baseline (% Monocytes)
|
8.569 % Monocytes
Standard Deviation 2.9774
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).
Final Visit (% Monocytes)
|
7.859 % Monocytes
Standard Deviation 2.3952
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).
Change from Baseline to Final Visit (% Monocytes)
|
-0.643 % Monocytes
Standard Deviation 3.0825
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).
Change from Baseline to Final Visit (g/L)
|
1.114 g/L
Standard Deviation 3.9131
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).
Baseline (g/L)
|
40.882 g/L
Standard Deviation 4.7314
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).
Final Visit (g/L)
|
42.341 g/L
Standard Deviation 5.2205
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).
Baseline (U/L)
|
219.471 U/L
Standard Deviation 60.3173
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).
Final Visit (U/L)
|
206.545 U/L
Standard Deviation 54.2160
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).
Change from Baseline to Final Visit (U/L)
|
-10.614 U/L
Standard Deviation 29.3505
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).
Baseline (U/L)
|
21.569 U/L
Standard Deviation 21.0364
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).
Final Visit (U/L)
|
17.727 U/L
Standard Deviation 11.5383
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).
Change from Baseline to Final Visit (U/L)
|
-1.136 U/L
Standard Deviation 9.0928
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).
Baseline (U/L)
|
29.392 U/L
Standard Deviation 11.4001
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).
Final Visit (U/L)
|
25.818 U/L
Standard Deviation 5.5793
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).
Change from Baseline to Final Visit (U/L)
|
-2.568 U/L
Standard Deviation 11.1426
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).
Baseline (mmol/L)
|
23.590 mmol/L
Standard Deviation 2.1776
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).
Final Visit (mmol/L)
|
24.748 mmol/L
Standard Deviation 2.2748
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).
Change from Baseline to Final Visit (mmol/L)
|
1.109 mmol/L
Standard Deviation 2.5307
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).
Change from Baseline to Final Visit (umol/L)
|
-0.319 umol/L
Standard Deviation 3.3429
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).
Baseline (umol/L)
|
4.695 umol/L
Standard Deviation 2.3525
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).
Final Visit (umol/L)
|
4.042 umol/L
Standard Deviation 2.8647
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).
Baseline (mmol/L)
|
4.241 mmol/L
Standard Deviation 1.4054
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).
Final Visit (mmol/L)
|
4.380 mmol/L
Standard Deviation 1.4918
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).
Change from Baseline to Final Visit (mmol/L)
|
0.326 mmol/L
Standard Deviation 1.4264
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).
Baseline (mmol/L)
|
102.959 mmol/L
Standard Deviation 3.2785
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).
Final Visit (mmol/L)
|
101.839 mmol/L
Standard Deviation 3.1748
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).
Change from Baseline to Final Visit (mmol/L)
|
-0.773 mmol/L
Standard Deviation 2.7935
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).
Final Visit (umol/L)
|
35.260 umol/L
Standard Deviation 12.4928
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).
Change from Baseline to Final Visit (umol/L)
|
4.159 umol/L
Standard Deviation 8.3375
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).
Baseline (umol/L)
|
32.032 umol/L
Standard Deviation 13.0954
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).
Baseline (mmol/L)
|
5.167 mmol/L
Standard Deviation 0.7358
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).
Final Visit (mmol/L)
|
4.851 mmol/L
Standard Deviation 0.9318
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).
Change from Baseline to Final Visit (mmol/L)
|
-0.361 mmol/L
Standard Deviation 0.9477
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).
Final Visit (U/L)
|
253.071 U/L
Standard Deviation 84.4854
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).
Change from Baseline to Final Visit (U/L)
|
-1.256 U/L
Standard Deviation 100.1911
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).
Baseline (U/L)
|
253.085 U/L
Standard Deviation 75.9762
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).
Baseline (mmol/L)
|
4.366 mmol/L
Standard Deviation 0.4274
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).
Final Visit (mmol/L)
|
4.337 mmol/L
Standard Deviation 0.6764
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).
Change from Baseline to Final Visit (mmol/L)
|
-0.038 mmol/L
Standard Deviation 0.7428
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).
Baseline (mmol/L)
|
138.510 mmol/L
Standard Deviation 2.7230
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).
Final Visit (mmol/L)
|
139.818 mmol/L
Standard Deviation 2.6787
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).
Change from Baseline to Final Visit (mmol/L)
|
1.409 mmol/L
Standard Deviation 2.8228
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).
Baseline (pH)
|
6.281 pH
Standard Deviation 0.6214
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).
Final Visit (pH)
|
6.598 pH
Standard Deviation 0.8079
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).
Change from Baseline to Final Visit (pH)
|
0.276 pH
Standard Deviation 0.8720
|
SECONDARY outcome
Timeframe: 4 weeks (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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).
Change from Baseline to Final Visit (Spec.Gravity)
|
0.000 Specific Gravity
Standard Deviation 0.0068
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).
Baseline (Specific Gravity)
|
1.022 Specific Gravity
Standard Deviation 0.0077
|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).
Final Visit (Specific Gravity)
|
1.020 Specific Gravity
Standard Deviation 0.0065
|
SECONDARY outcome
Timeframe: 4 weeks (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 any new or worsened clinically significant abnormal 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 |
Diclofenac Potassium Oral Solution
n=51 Participants
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).
|
1 Participants
|
Adverse Events
Diclofenac Potassium Oral Solution
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diclofenac Potassium Oral Solution
n=51 participants at risk
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
Injury, poisoning and procedural complications
Wound Secretion
|
2.0%
1/51 • 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
The Safety population included all subjects who have received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
The Safety population included all subjects who have received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Diclofenac Potassium Oral Solution
n=51 participants at risk
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
|
|---|---|
|
General disorders
Pyrexia
|
15.7%
8/51 • 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
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