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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02381132
• Other study ID #: LCR-MNK-155-01C
• Status: Terminated
• Phase: Phase 3
• First received: January 20, 2015
• Last updated: March 23, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Lotus Clinical Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (ß-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 Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Norco 7.5mg/325

• MNK155

Locations

Country	Name	City	State
United States	Lotus Clinical Research, LLC	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Neil Singla	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Pain Control	Patient Global Assessment	48 hours	No
Secondary	Post-operative Pain Control	Patient Global Assessment	120 hours	No
Secondary	Post-operative Pain Control as Assessed by the Healthcare Professional	Healthcare Professional Global Assessments	48 and 120 hours	No
Secondary	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	No
Secondary	Subject Reported Worst Pain (Secondary to Analgesic Gaps)	Assessment of Worst Pain- Numerical Rating Scale (NRS)	24 hours after treatment initiation	No
Secondary	Total Daily Acetaminophen Exposure	Number of Dosed of Acetaminophen	24 hours, 48 hours, 72 hours, 96 hours and 120 hours after treatment initation	No
Secondary	Sleep Disturbance	Assessment of Sleep Disturbance/Pain Interference with Sleep	24 hours, 48 hours and 72 hours after treatment initiation	No
Secondary	Opioid Related Symptoms	Opioid Related Symptom Distress Scale (ORSDS)	48 hours after treatment initiation	Yes
Secondary	Pill Diversion	Number of Pills Remaining and Accountability	Day 5	No