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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Depomed
• Treatments: Diclofenac; Pharmaceutical Solutions

Criteria

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.