Overview

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.