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

Post Operative Pain Clinical Trial

Official title: 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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

• NCT number: NCT02381132
• Study type: Interventional
• Source: Lotus Clinical Research, LLC
• Status: Terminated
• Phase: Phase 3
• Start date: November 2014
• Completion date: December 2015