Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco® 7.5mg/325mg when used for the treatment of moderate to severe post operative pain.
This is a single center, open label, prospective, randomized study on adult post operative subjects who are expected to require oral opioid analgesia for at least 48 hours after surgery. The main study drug of interest in this study is MNK 155. Norco® 7.5mg/325mg is being utilized only as active comparator.
Subjects will be at least 18 years of age and will be scheduled to undergo elective surgery. The following surgical types will be allowed, although the list is not all inclusive:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNK155 | Active Comparator | Hydrocodone Bitartrate/Acetaminophen Extended-Release Tablets |
|
| Norco 7.5mg/325mg | Active Comparator | Norco 7.5mg/325mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norco 7.5mg/325 | Drug |
| ||
| MNK155 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Control | Patient Global Assessment | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Control | Patient Global Assessment | 120 hours |
| Post-operative Pain Control as Assessed by the Healthcare Professional | Healthcare Professional Global Assessments |
Not provided
Inclusion Criteria:
Subjects who provide written informed consent prior to enrollment.
Male or female and 18 years of age or older.
Subjects who are scheduled to undergo elective general surgery including, but not limited to the following surgical types:
Subjects classified as American Society of Anesthesiologists (ASA class I-III).
Female subjects are eligible only if all of the following apply:
Subjects 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).
Subjects who are willing and capable of understanding and cooperating with the requirements of the study.
Subjects able to understand and communicate in English.
Exclusion Criteria:
1. Subjects with a medical condition that, in the Investigator's opinion, could adversely impact the subject'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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 14, 2020 | |
| Reset | Aug 31, 2020 | |
| Release | Mar 5, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 48 and 120 hours |
| Subject Satisfaction Regarding Ease of Use and Pill Burden | Patient Satisfaction/Ease of Use and Pill Burden Assessment | 48 hours and 120 hours after treatment initation |
| Subject Reported Worst Pain (Secondary to Analgesic Gaps) | Assessment of Worst Pain- Numerical Rating Scale (NRS) | 24 hours after treatment initiation |
| Total Daily Acetaminophen Exposure | Number of Dosed of Acetaminophen | 24 hours, 48 hours, 72 hours, 96 hours and 120 hours after treatment initation |
| Sleep Disturbance | Assessment of Sleep Disturbance/Pain Interference with Sleep | 24 hours, 48 hours and 72 hours after treatment initiation |
| Opioid Related Symptoms | Opioid Related Symptom Distress Scale (ORSDS) | 48 hours after treatment initiation |
| Pill Diversion | Number of Pills Remaining and Accountability | Day 5 |
| Reset | Mar 31, 2021 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2020 | Aug 31, 2020 | |||
| Mar 5, 2021 | Mar 31, 2021 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
Not provided
Not provided
Not provided