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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
Unnamed facility
Sheffield, Alabama, United States
Unnamed facility
Stanford, California, United States
Unnamed facility
City of Saint Peters, Missouri, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
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)
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)
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)
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)
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)
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Milwaukee, Wisconsin, United States
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)
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)
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)
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)
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)
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)
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)
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).
• Changes in vital sign measurements: Temperature (degrees C).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in vital sign measurements: Pulse Rate (beats/min).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in vital sign measurements: Respiratory Rate (breaths/min).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Platelet Count (10\^9/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - White Blood Cells (10\^9/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Basophils (%).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Eosinophils (%).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Neutrophils (%).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Hematology - Monocytes (%).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - LDH (U/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Urinalysis - pH.
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Time frame: 4 weeks (signed informed consent/assent to the final visit)
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).
• Physical examination findings including abnormal clinically significant findings
Time frame: 4 weeks (signed informed consent/assent to the final visit)