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

Phase 4

Completed

• Conditions: Disorder of Knee
• Interventions: Drug: Oxycodone

• Registration Number: NCT02391844
• Lead Sponsor: International Clinical Research Institute

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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Status Verified: 2015-11
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxycodone	Oxycodone	Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

International Clinical Research Institute; 🇺🇸 Overland Park, Kansas, United States