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

NCT02391844 | Completed Phase 4

• 1 other identifier: MNK795-ICRI-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Knee

Keywords

Knee; Post-Operative Pain; Xartemis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Screening to Week 4

Other Outcomes (1)

• Assessment of Treatment Satisfaction

  1 Week, 2 Weeks, and 4 Weeks Post Dose

Study Arms (1)

Oxycodone

OTHER

Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet

Drug: Oxycodone

Interventions

Oxycodone DRUG

Oxycodone with Acetaminophen Extended Release

Also known as: Xartemix XR

Oxycodone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• International Clinical Research Institute: lead
• Mallinckrodt: collaborator

Study Sites (1)

International Clinical Research Institute

Overland Park, Kansas, 66210, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Srinivas Nalamachu, MD

  International Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: March 18, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 7, 2016

Record last verified: 2015-11

Locations

US (1)