Clinical trial NCT02391844: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorder of Knee
Keywords: Knee
Post-Operative Pain
Xartemis
Lead sponsor: International Clinical Research Institute
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2015-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in pain Scores on the Numerical Rating Scale
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Screening to Week 4
Other outcomes:
measure: Assessment of Treatment Satisfaction
timeFrame: 1 Week, 2 Weeks, and 4 Weeks Post Dose
Locations:
city: Overland Park
country: United States
facility: International Clinical Research Institute
state: Kansas
Study officials:
affiliation: International Clinical Research Institute
name: Srinivas Nalamachu, MD
role: PRINCIPAL_INVESTIGATOR
References: