NCT02287350

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Depomed · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

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

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-11-10
• Last updated: 2017-07-11
• Results posted: 2017-07-11

Locations

5 sites across 1 country: United States