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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Depomed
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• Male and female subjects between 12-17 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 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.