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

NCT02381132 | Terminated Phase 3

• 1 other identifier: LCR-MNK-155-01C
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Control

  Patient Global Assessment

  48 hours

Secondary Outcomes (8)

• Post-operative Pain Control

  120 hours

• Post-operative Pain Control as Assessed by the Healthcare Professional

  48 and 120 hours

• Subject Satisfaction Regarding Ease of Use and Pill Burden

  48 hours and 120 hours after treatment initation

• Subject Reported Worst Pain (Secondary to Analgesic Gaps)

  24 hours after treatment initiation

• Total Daily Acetaminophen Exposure

  24 hours, 48 hours, 72 hours, 96 hours and 120 hours after treatment initation

Study Arms (2)

MNK155

ACTIVE COMPARATOR

Hydrocodone Bitartrate/Acetaminophen Extended-Release Tablets

Drug: MNK155

Norco 7.5mg/325mg

ACTIVE COMPARATOR

Norco 7.5mg/325mg

Drug: Norco 7.5mg/325

Interventions

Norco 7.5mg/325 DRUG

Norco 7.5mg/325mg

MNK155 DRUG

MNK155

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Neil Singla: lead
• Mallinckrodt: collaborator

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: March 6, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

US (1)