Disorder of Knee Clinical Trial
Official title:
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
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.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01881087 -
Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy
|
Phase 4 |