drugset / Trial / NCT02508935

Pharmacokinetics (PK) and Safety Study of XARTEMIS® XR in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain

NCT02508935

Phase 4 Terminated 23 enrolled Mallinckrodt
NaSingle-groupOpen-labelTreatment

Summary

Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will assess the safety of administering multiple doses of XARTEMIS XR in this population.

Timeline

Start
2015-11-20
Primary completion
2017-04-26
Completion
2017-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg
Subject Oxycodone Other / unclassified 7.5 mg

Indications

No indication recorded.