NCT02391844

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: International Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Disorder of Knee

Interventions

Type	Name	Description
DRUG	Oxycodone	Oxycodone with Acetaminophen Extended Release

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-03-18
• Last updated: 2016-01-07

Locations

1 site across 1 country: United States