Disorder of Knee
Conditions
Keywords
Knee, Post-Operative Pain, Xartemis
Brief summary
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
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
Interventions
DRUGOxycodone
Oxycodone with Acetaminophen Extended Release
Sponsors
Mallinckrodt
International Clinical Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee 2. Read and understand English and comprehend the procedures associated with participating in a clinical trial. 3. Signed an IRB approved consent form and HIPAA authorization 4. 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
1. Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial 2. Allergy to Oxycodone or Acetaminophen. 3. Uncontrolled pain or other pain conditions that may interfere with evaluation 4. Pregnant women 5. Women who are trying to become pregnant 6. Women who are breastfeeding 7. Patient who is deemed to be medically unstable by the principal investigator 8. History of Alcohol, opioid or substance abuse in the last 2 yrs 9. History of sleep apnea that requires CPAP 10. History of serious respiratory illness 11. History of Gastric bypass 12. Prior use of opiates at doses higher than 90mg Morphine equivalent dosing 13. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain Scores on the Numerical Rating Scale | Baseline to Week 4 | Change in pain Scores on the Numerical Rating Scale from baseline (before taking the first dose of study medication) through 4 week study participation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Screening to Week 4 | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Treatment Satisfaction | 1 Week, 2 Weeks, and 4 Weeks Post Dose | Patient/Investigator Global assessment of treatment satisfaction will be completed 3 follow-up visits after screening. |
Countries
United States
Outcome results
None listed