Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
- Registration Number
- NCT02287350
- Lead Sponsor
- Depomed
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Male and female subjects between 2-12 years of age.
- Subjects must be post-op, having mild or moderate acute pain.
Other inclusions apply.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description diclofenac potassium oral solution diclofenac potassium oral solution 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
- Primary Outcome Measures
Name Time Method 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 (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 (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 Outcome Measures
Name Time Method 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 (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 (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 (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).
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 (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 (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