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

Primary Purpose

Disorder of Knee

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Oxycodone

About this trial

This is an interventional treatment trial for Disorder of Knee focused on measuring Knee, Post-Operative Pain, Xartemis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee
Read and understand English and comprehend the procedures associated with participating in a clinical trial.
Signed an IRB approved consent form and HIPAA authorization
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:

Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial
Allergy to Oxycodone or Acetaminophen.
Uncontrolled pain or other pain conditions that may interfere with evaluation
Pregnant women
Women who are trying to become pregnant
Women who are breastfeeding
Patient who is deemed to be medically unstable by the principal investigator
History of Alcohol, opioid or substance abuse in the last 2 yrs
History of sleep apnea that requires CPAP
History of serious respiratory illness
History of Gastric bypass
Prior use of opiates at doses higher than 90mg Morphine equivalent dosing
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

Sites / Locations

International Clinical Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Oxycodone

Arm Description

Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT02391844

First Posted

May 15, 2014

Last Updated

January 5, 2016

Sponsor

International Clinical Research Institute

Collaborators

Mallinckrodt

1. Study Identification

Unique Protocol Identification Number

NCT02391844

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Clinical Research Institute

Collaborators

Mallinckrodt

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disorder of Knee

Keywords

Knee, Post-Operative Pain, Xartemis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxycodone

Arm Type

Other

Arm Description

Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet

Intervention Type

Drug

Intervention Name(s)

Oxycodone

Other Intervention Name(s)

Xartemix XR

Intervention Description

Oxycodone with Acetaminophen Extended Release

Primary Outcome Measure Information:

Title

Change in pain Scores on the Numerical Rating Scale

Description

Change in pain Scores on the Numerical Rating Scale from baseline (before taking the first dose of study medication) through 4 week study participation.

Time Frame

Baseline to Week 4

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Description

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

Screening to Week 4

Other Pre-specified Outcome Measures:

Title

Assessment of Treatment Satisfaction

Description

Patient/Investigator Global assessment of treatment satisfaction will be completed 3 follow-up visits after screening.

Time Frame

1 Week, 2 Weeks, and 4 Weeks Post Dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee Read and understand English and comprehend the procedures associated with participating in a clinical trial. Signed an IRB approved consent form and HIPAA authorization 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: Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial Allergy to Oxycodone or Acetaminophen. Uncontrolled pain or other pain conditions that may interfere with evaluation Pregnant women Women who are trying to become pregnant Women who are breastfeeding Patient who is deemed to be medically unstable by the principal investigator History of Alcohol, opioid or substance abuse in the last 2 yrs History of sleep apnea that requires CPAP History of serious respiratory illness History of Gastric bypass Prior use of opiates at doses higher than 90mg Morphine equivalent dosing 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Srinivas Nalamachu, MD

Organizational Affiliation

International Clinical Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Clinical Research Institute

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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