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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Knee
• Intervention / Treatment: Drug: Oxycodone

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • International Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Oxycodone; Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet	Drug: Oxycodone; Oxycodone with Acetaminophen Extended Release; Other Names: Xartemix XR

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Treatment Satisfaction	Patient/Investigator Global assessment of treatment satisfaction will be completed 3 follow-up visits after screening.	1 Week, 2 Weeks, and 4 Weeks Post Dose

Collaborators and Investigators

• Sponsor: International Clinical Research Institute
• Collaborators: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Knee; Post-Operative Pain; Xartemis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: MNK795-ICRI-001