Clinical Trial: PK and Safety Study of XARTEMIS® XR (7.5 mg Oxycodone HCl/325 mg APAP) in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of XARTEMIS® XR (7.5 Oxycodone Hydrochloride/325 mg Acetaminophen) in Postsurgical Adolescent Subjects (Ages 12 to 17) With Moderate

Brief 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.

Detailed Summary:
Sponsor: Mallinckrodt

Current Primary Outcome:

  • Time to reach steady state [ Time Frame: 12 hours ]
  • Area under the curve [ Time Frame: 12 hours ]
    Area under the concentration time curves after the first and last dose
  • Peak exposure [ Time Frame: 12 hours ]
    Peak exposure
  • Half-life [ Time Frame: 12 hours ]
    Apparent elimination half-life
  • Time to peak exposure [ Time Frame: 12 hours ]
    Observed time when peak exposure occurred


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mallinckrodt

Dates:
Date Received: June 17, 2015
Date Started: June 2015
Date Completion: March 2017
Last Updated: July 13, 2016
Last Verified: July 2016