Overview

Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures

Status:
Completed

Trial end date:
2014-08-01

Target enrollment:

Participant gender:

Summary

A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety and efficacy of SPRIX.

Phase:

Phase 3

Details

Lead Sponsor:

American Regent, Inc.
Luitpold Pharmaceuticals

Treatments:

Ketorolac
Ketorolac Tromethamine