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

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.

Study Overview

• Status: Terminated
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: MNK155; Drug: Norco 7.5mg/325

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects who provide written informed consent prior to enrollment.
2. Male or female and 18 years of age or older.

3. 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
4. Subjects classified as American Society of Anesthesiologists (ASA class I-III).

5. 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;
6. 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).
7. Subjects who are willing and capable of understanding and cooperating with the requirements of the study.
8. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Neil Singla
• Collaborators: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Estimate): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: LCR-MNK-155-01C