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Completed

NCT Number: NCT02287350

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

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Key information

Conditions

Pain Acute Pain Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheffield, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diclofenac potassium oral solution

Drug

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

Other names: diclofenac

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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).

  8. 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 outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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 (%).

  15. 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 (%).

  16. 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 (%).

  17. 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 (%).

  18. 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 (%).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. 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).

  26. 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).

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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.

  33. 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.

  34. 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

Sponsors and collaborators

Lead sponsor

Depomed

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2014
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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