Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02287350

Enrollment

Registered

2014-11-10

Start date

2014-09-30

Completion date

2016-01-31

Last updated

2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain, NSAID, nonsteroidal anti-inflammatory drug

Brief summary

As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.

Detailed description

This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.

Interventions

DRUGdiclofenac potassium oral solution

Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

Inclusion criteria

* Male and female subjects between 2-12 years of age. * Subjects must be post-op, having mild or moderate acute pain. Other inclusions apply.

Exclusion criteria

* Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication. * Subject has been taking analgesics for 48-72 hours prior to Screening. * Subject has a history of any GI event greater than 6 months before Screening. * Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen. * Subject is requiring treatment for pre-existing hypertension. Other exclusions apply.

Design outcomes

Primary

Measure	Time frame	Description
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 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• Cmax: maximum concentration (ng/mL)
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• Tmax: time to maximum concentration (hr)
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• λz: elimination rate constant (1/hr)
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• t1/2: terminal elimination half-life (hr)
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr\*ng/mL)
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr\*ng/mL)
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• CL/F: apparent clearance (mL/hr).
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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)	• Vz/F: apparent volume of distribution (mL).

Secondary

Measure	Time frame	Description
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Platelet Count (10\^9/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - White Blood Cells (10\^9/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Basophils (%).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Eosinophils (%).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Neutrophils (%).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Lymphocytes (%).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Hematology - Monocytes (%).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Albumin (g/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
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).	4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)	• Treatment emergent AEs (TEAEs)
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - LDH (U/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Urinalysis - pH.
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Urinalysis - Specific Gravity.
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).	4 weeks (signed informed consent/assent to the final visit)	• Physical examination findings including abnormal clinically significant findings
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
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).	4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)	• Serious adverse events (SAEs)
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).	4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)	• Withdrawals due to AEs
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).	4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)	• Deaths
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in vital sign measurements: Temperature (degrees C).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in vital sign measurements: Pulse Rate (beats/min).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in vital sign measurements: Respiratory Rate (breaths/min).
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).	4 weeks (signed informed consent/assent to the final visit)	• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	51
Total	51

Arm

Count

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.

Total

Baseline characteristics

Characteristic	Diclofenac Potassium Oral Solution
Age, Continuous	6.4 years STANDARD_DEVIATION 3.1
Sex: Female, Male Female	28 Participants
Sex: Female, Male Male	23 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	8 / 51
serious Total, serious adverse events	2 / 51

Outcome results

Primary

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: maximum concentration (ng/mL)

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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)	433.9 ng/mL	Standard Deviation 297.53
Diclofenac Potassium Oral Solution	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)	0.000 ng/mL	Standard Deviation 0
Diclofenac Potassium Oral Solution	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)	378.471 ng/mL	Standard Deviation 315.3756
Diclofenac Potassium Oral Solution	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)	260.484 ng/mL	Standard Deviation 161.9306
Diclofenac Potassium Oral Solution	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)	178.544 ng/mL	Standard Deviation 108.9297
Diclofenac Potassium Oral Solution	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)	67.394 ng/mL	Standard Deviation 54.5705
Diclofenac Potassium Oral Solution	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)	22.964 ng/mL	Standard Deviation 21.4744
Diclofenac Potassium Oral Solution	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)	15.042 ng/mL	Standard Deviation 13.0339

Primary

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).

• Tmax: time to maximum concentration (hr)

Time frame: 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.

Arm	Measure	Value (MEDIAN)
Diclofenac Potassium Oral Solution	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).	0.250 hr

Primary

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).

• λz: elimination rate constant (1/hr)

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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).	0.47329 1/hr	Standard Deviation 0.141463

Primary

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).

• t1/2: terminal elimination half-life (hr)

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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).	1.692 hr	Standard Deviation 0.8811

Primary

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).

• 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)

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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).	454.544 hr*ng/mL	Standard Deviation 219.3114

Primary

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).

• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr\*ng/mL)

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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).	491.915 hr*ng/mL	Standard Deviation 244.0359

Primary

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).

• CL/F: apparent clearance (mL/hr).

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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).	25927.177 mL/hr	Standard Deviation 12582.7293

Primary

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).

• Vz/F: apparent volume of distribution (mL).

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Diclofenac Potassium Oral Solution	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).	66845.275 mL	Standard Deviation 64351.3897

Secondary

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).

• Treatment emergent AEs (TEAEs)

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Diclofenac Potassium Oral Solution	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).	16 Participants

Secondary

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).

• Serious adverse events (SAEs)

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Diclofenac Potassium Oral Solution	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).	2 Participants

Secondary

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).

• Withdrawals due to AEs

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Diclofenac Potassium Oral Solution	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).	0 Participants

Secondary

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).

• Deaths

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Diclofenac Potassium Oral Solution	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).	0 Participants

Secondary