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

Disorder of Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391844
• Other study ID #: MNK795-ICRI-001
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2014
• Last updated: January 5, 2016
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: International Clinical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Knee
• Pain, Postoperative

Intervention

Drug:
• Oxycodone
Oxycodone with Acetaminophen Extended Release

Locations

Country	Name	City	State
United States	International Clinical Research Institute	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
International Clinical Research Institute	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	Yes