Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery

Study Overview
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Brief Summary
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This is a pilot trial using this product in patients for the management of pain after outpatient arthroscopic knee surgery. This is an open-label study and the two active ingredients are well known pharmacologic entities.

Detailed Description
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The objective of this single center is to evaluate the safety and efficacy of Oxycodone Extended Release (MNK-795) in postoperative pain following common musculoskeletal surgical procedures. Knee surgery being the most common surgery performed in the US, the investigators chose the model. The investigators also want to look at the flexible-dosing and titration which is the common way pain managed by clinicians. This is an open-label study of MNK 795 to be described in the procedures section. Primary endpoint: • Change in pain from baseline (before taking the first dose of study medication) measured on NRS Secondary endpoints: Patient/Investigator Global assessment of treatment satisfaction Safety evaluation with adverse event monitoring

Official Title
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Open-Label Parallel Group Flexible Dosing & Titration Study to Evaluate the Efficacy, Safety of Oxycodone/APAP Extended Release Formulation Xartemisxr® in the Management of Post-Operative Pain Following Outpatient Arthroscopic Knee Surgery

Conditions
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Disorder of Knee

Intervention / Treatment
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* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee Read and understand English and comprehend the procedures associated with participating in a clinical trial. Signed an IRB approved consent form and HIPAA authorization Patients with a pain intensity score of 4 or above on the 0-10 numerical rating scale (0 is no pain, 10 is the worst pain imaginable) Exclusion Criteria: Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial Allergy to Oxycodone or Acetaminophen. Uncontrolled pain or other pain conditions that may interfere with evaluation Pregnant women Women who are trying to become pregnant Women who are breastfeeding Patient who is deemed to be medically unstable by the principal investigator History of Alcohol, opioid or substance abuse in the last 2 yrs History of sleep apnea that requires CPAP History of serious respiratory illness History of Gastric bypass Prior use of opiates at doses higher than 90mg Morphine equivalent dosing Will limit the study medication to 4 tab at each dosing and to total dose of 8 tab for 24 hrs. Subjects needing doses higher than that, based on their current opioid dose, will not be enrolled or discontinued

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oxycodone<br>Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet | Drug: Oxycodone<br>* Oxycodone with Acetaminophen Extended Release<br>* Other names: Xartemix XR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain Scores on the Numerical Rating Scale | Change in pain Scores on the Numerical Rating Scale from baseline (before taking the first dose of study medication) through 4 week study participation. | Baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Screening to Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Post-Operative Pain, Xartemis