NCT02508935

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

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 to Severe Acute Pain

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	XARTEMIS XR	XARTEMIS XR \[7.5 mg oxycodone hydrochloride and 325 mg acetaminophen (APAP)\] Extended-Release Tablets

Timeline

• Start date: 2015-11-20
• Primary completion: 2017-04-26
• Completion: 2017-04-26
• First posted: 2015-07-27
• Last updated: 2020-01-22
• Results posted: 2020-01-22

Locations

2 sites across 1 country: United States