drugset / Trial / NCT01819610

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

NCT01819610 ↗

Phase 3 Completed 60 enrolled American Regent, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-02
Primary completion
2014-03
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject SPRIX (intranasal ketorolac tromethemine) Unknown — Intranasal

Indications

No indication recorded.