A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Abdominal surgery Soft tissue surgery Orthopedic surgery Spine surgery Genitourinary surgery

Official Title
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A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Norco 7.5mg/325
* Drug: MNK155


Participation Criteria
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Eligibility Criteria
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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: Abdominal surgery Orthopedic surgery Spine surgery Genitourinary surgery Subjects 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MNK155<br>Hydrocodone Bitartrate/Acetaminophen Extended-Release Tablets | Drug: MNK155<br> <br> |
| Active Comparator: Norco 7.5mg/325mg<br>Norco 7.5mg/325mg | Drug: Norco 7.5mg/325<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Control | Patient Global Assessment | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |