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Completed

NCT Number: NCT02391844

Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following 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.

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Key information

Conditions

Disorder of Knee Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

International Clinical Research Institute

Overland Park, Kansas, 66210, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

Oxycodone with Acetaminophen Extended Release

Other names: Xartemix XR

Primary outcomes

  1. Change in pain Scores on the Numerical Rating Scale

    Time frame: 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 outcomes

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

    Time frame: Screening to Week 4

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

Other outcomes

  1. Assessment of Treatment Satisfaction

    Time frame: 1 Week, 2 Weeks, and 4 Weeks Post Dose

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

Sponsors and collaborators

Lead sponsor

International Clinical Research Institute

Other

Collaborators

  • Mallinckrodt

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 18, 2015
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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