Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Depomed
Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
