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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: diclofenac potassium oral solution

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States
  • California
    • Stanford, California, United States
  • Missouri
    • Saint Peters, Missouri, United States
  • Texas
    • Dallas, Texas, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diclofenac potassium oral solution; 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.	Drug: diclofenac potassium oral solution; Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.; Other Names: diclofenac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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 (6 of 8).	• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)	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).	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).	6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	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	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).	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).	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).	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).	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).	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).	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).	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).	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).	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 (%).	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 (%).	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 (%).	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 (%).	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 (%).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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.	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.	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	4 weeks (signed informed consent/assent to the final visit)

Collaborators and Investigators

• Sponsor: Depomed

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: pain; acute pain; NSAID; moderate pain; mild pain; mild acute pain; moderate acute pain; mild or moderate acute pain; nonsteroidal anti-inflammatory drug
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 81-0074