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

NCT ID: NCT02391844

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-01-31

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

Conditions

Disorder of Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxycodone

Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet

Group Type: OTHER

Oxycodone

Intervention Type: DRUG

Oxycodone with Acetaminophen Extended Release

Interventions

Oxycodone

Oxycodone with Acetaminophen Extended Release

Intervention Type: DRUG

Other Intervention Names

Xartemix XR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

International Clinical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srinivas Nalamachu, MD

Role: PRINCIPAL_INVESTIGATOR

International Clinical Research Institute

Locations

International Clinical Research Institute

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

MNK795-ICRI-001

Identifier Type: -

Identifier Source: org_study_id