Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
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|ClinicalTrials.gov Identifier: NCT02391844|
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : January 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Disorder of Knee||Drug: Oxycodone||Phase 4|
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.
• Change in pain from baseline (before taking the first dose of study medication) measured on NRS
- Patient/Investigator Global assessment of treatment satisfaction
- Safety evaluation with adverse event monitoring
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet
Oxycodone with Acetaminophen Extended Release
Other Name: Xartemix XR
- Change in pain Scores on the Numerical Rating Scale [ Time Frame: 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.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Screening to Week 4 ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Assessment of Treatment Satisfaction [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391844
|United States, Kansas|
|International Clinical Research Institute|
|Overland Park, Kansas, United States, 66210|
|Principal Investigator:||Srinivas Nalamachu, MD||International Clinical Research Institute|