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

NCT02287350 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Depomed
Phase	Phase 4
Status	COMPLETED
Enrolment	51
Start date	2014-09
Completion	2016-01

Conditions

• Pain

Interventions

• diclofenac potassium oral solution

Primary outcomes

• 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)

Countries

United States