Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | January 2016 |
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
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.
outpatient arthroscopic knee surgery. This is an open-label study and the two active
ingredients are well known pharmacologic entities.
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
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
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
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