Acute PainPhase 4NCT02508935
Pharmacokinetics (PK) and Safety Study of XARTEMIS® XR in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
A Phase 4 study testing XARTEMIS XR in people with Acute Pain, run by Mallinckrodt at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- XARTEMIS XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2015to 26 Apr 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Pathologic, iatrogenic or surgical condition that would compromise subject's ability to swallow, absorb, metabolize, or excrete XARTEMIS XR.
- History of a GI event within 6 months prior to screening.
- Subject has used any product containing OC or APAP within 48 hours prior to the first dose of XARTEMIS XR.
- Any other medical condition, abnormal vital sign (blood pressure, pulse rate, respiratory rate), body temperature, pulse oximetry; or any physical examination or ECG finding at screening which would preclude safe participation in a clinical study.
- Received any investigational product or device within 30 days before screening, or is scheduled to receive an investigational device or another investigational drug during the course of this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Health Systems
Durham, North Carolina, 27710
University of Pittsburgh Medical Center, University of Pittsburgh Physicians
Pittsburgh, Pennsylvania, 15213
About this study
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 to Severe Acute Pain
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
- Being tested
- XARTEMIS XR
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XARTEMIS XRDrug
XARTEMIS XR [7.5 mg oxycodone hydrochloride and 325 mg acetaminophen (APAP)] Extended-Release Tablets
| Study group | Role | What they receive |
|---|---|---|
| XARTEMIS XR | Experimental | All participants received XARTEMIS XR Receives: Drug: XARTEMIS XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach Steady State
The time to reach steady state in participants who received all 5 doses
Measured: 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.
Measured: within approximately 12 hours (12.08 hours)
Maximum Observed Plasma Concentration (Cmax)
The highest concentration of study drug within 12 hours.
Measured: 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.
Measured: 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.
Measured: within approximately 12 hours (12.08 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start20 Nov 2015
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508935
- Sponsor's protocol ID
- MNK15000300
- Status last verified
- May 2018
- First submitted
- 17 Jun 2015
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 to Severe Acute Pain
- ClinicalTrials.gov ID
- NCT02508935
- Acronym / sponsor ID
- MNK15000300
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XARTEMIS XR | Experimental | Drug: XARTEMIS XRAll participants received XARTEMIS XR |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XARTEMIS XRXARTEMIS XR [7.5 mg oxycodone hydrochloride and 325 mg acetaminophen (APAP)] Extended-Release Tablets | Drug | XARTEMIS XR |
Primary outcome
Time to Reach Steady State
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: within approximately 12 hours (12.08 hours)
The time at which the maximum plasma concentration (Cmax) is reached.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Mallinckrodt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XARTEMIS XR in people with Acute Pain, run by Mallinckrodt at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reach Steady State (time frame: within 60 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.