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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

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

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

Arms, Groups and Cohorts

  • Experimental: diclofenac potassium oral solution
    • 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.

Clinical Trial Outcome Measures

Primary Measures

  • 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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 Measures

  • 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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 (5.5 of 7).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 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).
    • Time Frame: 4 weeks (signed informed consent/assent to the final visit)
    • • Physical examination findings including abnormal clinically significant findings

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Depomed
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.