Post Operative Pain
Conditions
Keywords
Pain
Brief summary
The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute moderate to severe post operative pain to generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.
Interventions
DRUGPercocet
10mg/650mg
DRUGXartemis
15mg/650mg
Sponsors
Mallinckrodt
Lotus Clinical Research, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who provide written informed consent prior to enrollment * Male or female and 18 years of age or older. * Patients who are scheduled to undergo elective general surgery including, but not limited to the following surgical types: * Abdominal surgery * Orthopedic surgery * Spine surgery * Genitourinary surgery * Patient classified as American Society of Anesthesiologists (ASA class I-III). * Female subjects are eligible only if all of the following apply: * Not pregnant (subjects of child bearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test before surgery); * Not lactating; * Not planning to become pregnant within the duration of the study; * Patients who are expected to have acute pain requiring oral opioid analgesics for at least 48 hours during the post operative period (either inpatient or outpatient). * Patient must report a categorical pain rating of moderate to severe on a scale of none, mild, moderate, or severe prior to randomization. * Patients who are willing and capable of understanding and cooperating with the requirements of the study. * Patients able to understand and communicate in English.
Exclusion criteria
* Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, or any other clinically significant medical condition that may preclude safe study participation * Patients who have a known severe allergy or hypersensitivity to opioid analgesics, anesthetics, APAP (acetaminophen.) * Patients who have a history of intolerance to short term opioid use. * Patients who have abused any prescription medication or alcohol within two years before the start of the study. * Patients who require an additional scheduled surgical procedure within 48 hours of the surgery. * Patients who have a history of seizures, or are currently taking anticonvulsants. * Patients who have dysphagia and/or cannot swallow study medication whole. * Patient who is unable to adequately communicate with study staff, properly give informed consent, or otherwise comply with study procedures. * Patient who has participated in another clinical trial of an investigational drug or device within 30 days of screening visit or is schedule to receive an investigational product while participating in the study. Post operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non Inferiority | 48 Hours | To demonstrate the non inferiority of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute post operative pain when compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours. The statistical comparison of interest will be the patient global assessment of analgesic effect administered at 48 hours after treatment initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment | 120 Hours | To assess patient global assessments at 120 hours after treatment initiation for Xartemis 15mg/650mg by mouth every 12 hours compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Professional Global Assessment | 48 Hours | To assess healthcare professional global assessments at 48 hours and 120 hours after treatment initiation for Xartemis 15mg/650mg by mouth every 12 hours compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours. |
Countries
United States
Outcome results
None listed