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

Completed · Phase 4

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02287350

Run by

Depomed

People needed

51

Starts

2014-09-01

Expected to finish

2016-01-01

Last updated by the study team

2017-07-11

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects between 2-12 years of age.
• Subjects must be post-op, having mild or moderate acute pain.
• Other inclusions apply.

You may not qualify if…

• 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.

Where it is running

• Study site — Sheffield, Alabama, United States
• Study site — Stanford, California, United States
• Study site — City of Saint Peters, Missouri, United States
• Study site — Dallas, Texas, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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