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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percocet | Active Comparator | Oxycodone/APAP (acetaminophen) |
|
| Xartemis | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percocet | Drug | 10mg/650mg |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Non Inferiority | 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. | 48 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment | 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. | 120 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Professional Global Assessment | 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. | 48 Hours |
| Healthcare Professional Global Assessment |
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:
Patient classified as American Society of Anesthesiologists (ASA class I-III).
Female subjects are eligible only if all of the following apply:
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:
Post operative Exclusion Criteria at Randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Resarch,LLC | Pasadena | California | 91105 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 5, 2021 | |
| Reset | Mar 31, 2021 |
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| Xartemis | Drug | 15mg/650mg |
|
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. |
| 120 Hours |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 5, 2021 | Mar 31, 2021 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
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