Conditions: Pain
Keywords: pain NSAID moderate pain mild pain acute pain mild acute pain moderate acute pain mild or moderate acute pain
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief 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.

Detailed description:
Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Arms:
arm 1: 25mg/every 6hrs/up to 4 days treatment

Interventions: intervention 1: Zipsor®
Intervention descriptions: intervention 1: Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.

Protocol document: