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

Phase 4

Terminated

• Conditions: Acute Pain
• Interventions: Drug: XARTEMIS XR

• Registration Number: NCT02508935
• Lead Sponsor: Mallinckrodt

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-27
• Study Start: 2015-11-20
• Primary Completion: 2017-04-26
• Study Completion: 2017-04-26
• Status Verified: 2018-05
• Results First Submitted: 2019-12-12
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XARTEMIS XR	XARTEMIS XR	All participants received XARTEMIS XR

Primary Outcome Measures

Name	Time	Method
Time to Reach Steady State	within 60 hours	The time to reach steady state in participants who received all 5 doses
Area Under the Concentration-time Curve (AUC) From Time Zero (AUC0) to the Time of the Last Quantifiable Plasma Sample (AUClast)	within approximately 12 hours (12.08 hours)	Elimination constant estimates required for the calculation of the planned AUC0-12 hours were not available. AUClast therefore provided the best available measure of exposure, effectively representing AUC0-12 hours for both moieties. While considered the best available measure, it also remains inaccurate because of the extended-release formulation and the lack of data beyond the 12.08-hour time point.
Maximum Observed Plasma Concentration (Cmax)	within approximately 12 hours (12.08 hours)	The highest concentration of study drug within 12 hours.
Apparent Plasma Terminal Drug Elimination Half-life (T1/2)	within approximately 12 hours (12.08 hours)	PK parameters are determined after a single administration of study drug on Day 1. Plasma concentrations that are below the level of quantification (BLQ) are set to 0 before Tmax, with the exception that a BLQ value occurring between measurable concentrations is set to missing. BLQ values that occur after Tmax are set to missing.
Time of Maximum Observed Plasma Concentration (Tmax)	within approximately 12 hours (12.08 hours)	The time at which the maximum plasma concentration (Cmax) is reached.

Trial Locations

Locations (2)

Duke University Health Systems; 🇺🇸 Durham, North Carolina, United States

University of Pittsburgh Medical Center, University of Pittsburgh Physicians; 🇺🇸 Pittsburgh, Pennsylvania, United States