Conditions: Pain
Keywords: pain moderate pain mild pain acute pain mild acute pain moderate acute pain mild or moderate acute pain NSAID nonsteroidal anti-inflammatory drug
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 51
Healthy volunteers: no

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.

Arms:
arm 1: 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.

Interventions: intervention 1: diclofenac potassium oral solution
Intervention descriptions: intervention 1: Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.

Protocol document: