drugset / Trial / NCT02102516

SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures

NCT02102516

Phase 3 Completed 45 enrolled Egalet Ltd
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.

Timeline

Start
2014-03
Primary completion
2015-06
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 3.15 mg Intranasal
Subject Ketorolac Other / unclassified 5.25 mg Intranasal
Subject Ketorolac Other / unclassified 10.5 mg Intranasal
Subject Ketorolac Other / unclassified 15.75 mg Intranasal
Subject Ketorolac Other / unclassified 31.5 mg Intranasal

Indications

No indication recorded.