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

Depomed

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: diclofenac potassium oral solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02287350

81-0074

Details and patient eligibility

About

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 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.

Enrollment

51 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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.