Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute

Completed · Phase 4

Conditions studied: Pain

In brief

As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Key facts

Study ID

NCT01982539

Run by

Depomed

People needed

25

Starts

2013-11-01

Expected to finish

2014-09-01

Last updated by the study team

2020-05-07

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects between 12-17 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 analgesic 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 has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication.
• 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

Full record on ClinicalTrials.gov

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