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

NCT02508935 | Terminated Phase 4 Results

• 1 other identifier: MNK15000300
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (5)

• Time to Reach Steady State

  The time to reach steady state in participants who received all 5 doses

  within 60 hours

• Area Under the Concentration-time Curve (AUC) From Time Zero (AUC0) to the Time of the Last Quantifiable Plasma Sample (AUClast)

  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.

  within approximately 12 hours (12.08 hours)

• Maximum Observed Plasma Concentration (Cmax)

  The highest concentration of study drug within 12 hours.

  within approximately 12 hours (12.08 hours)

• Apparent Plasma Terminal Drug Elimination Half-life (T1/2)

  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.

  within approximately 12 hours (12.08 hours)

• Time of Maximum Observed Plasma Concentration (Tmax)

  The time at which the maximum plasma concentration (Cmax) is reached.

  within approximately 12 hours (12.08 hours)

Study Arms (1)

XARTEMIS XR

EXPERIMENTAL

All participants received XARTEMIS XR

Drug: XARTEMIS XR

Interventions

XARTEMIS XR DRUG

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

XARTEMIS XR

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or nonpregnant, nonlactating females between 12 and 17 years of age.
• Minimum weight of 100 pounds (45 kg); body mass index (BMI) \>5% and \<95% for their age.
• Moderate or severe acute pain \[as determined from the Numerical Pain Rating scale (NPRS)\]; must have a level of 4 or more) after surgical procedure requiring hospitalization.
• If, of child-bearing/reproductive potential, must abstain from unprotected sexual activity during study and 2 weeks after study exit.
• Females of childbearing potential must have negative pregnancy test.
• Subject's legally authorized representative (eg, parent, legal guardian) must sign a parental permission/informed consent and subject must sign an assent.
• Subject and subject's parent/legal guardian must be able to read, understand, and follow study procedures and requirements and communicate meaningfully in English.

You may not qualify if:

• Subject is from a vulnerable population (including mentally disabled children), other than a pediatric population.
• Subject requires surgery that could influence the study outcome.
• Abnormal electrocardiogram (ECG).
• Screening pulse oximetry reading of \<95% while awake.
• Has presence of human immunodeficiency virus (HIV) or indications of hepatitis A, B or C.
• Lab values greater than 2 times the upper limit of normal.
• History of renal disease or bleeding or clotting disorders or conditions.
• Known or suspected alcoholism, marijuana or illicit drug abuse or misuse within 2 years before screening.
• Smoked or used nicotine-containing products within 6 months prior to screening.
• Psychiatric disorders, such as major depression disorder, anxiety disorders, or psychotic disorders within 6 months prior to screening. A history of attention deficit hyperactivity disorder requiring medication is acceptable.
• Diagnosis of epilepsy or other seizure disorder.
• Previous cardiothoracic surgery.
• Conditions which might be specifically contraindicated or require caution while using OC, APAP, and/or ibuprofen.
• Drug allergy, hypersensitivity, or intolerance including OC, APAP, ibuprofen or excipients, or any opioid drug product.
• Donated or had significant loss of whole blood (480 mL or more) within 30 days of or plans to donate blood or plasma during the course of the study.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (2)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center, University of Pittsburgh Physicians

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 27, 2015
• Study Start: November 20, 2015
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)