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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

Information source: Lotus Clinical Research, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Pain

Intervention: Norco 7.5mg/325 (Drug); MNK155 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Neil Singla

Overall contact:
Anne Arriaga, Phone: 626-397-3412, Email: anne@lotuscr.com

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 Details

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

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

Primary outcome: Post-operative Pain Control

Secondary outcome:

Post-operative Pain Control

Post-operative Pain Control as Assessed by the Healthcare Professional

Subject Satisfaction Regarding Ease of Use and Pill Burden

Subject Reported Worst Pain (Secondary to Analgesic Gaps)

Total Daily Acetaminophen Exposure

Sleep Disturbance

Opioid Related Symptoms

Pill Diversion

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 (╬▓-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.

Locations and Contacts

Anne Arriaga, Phone: 626-397-3412, Email: anne@lotuscr.com

Lotus Clinical Research, LLC, Pasadena, California 91105, United States; Recruiting
Anne Arriaga, Phone: 626-397-3412, Email: anne@lotuscr.com
Sonia Singla, DO, Principal Investigator
Additional Information

Starting date: November 2014
Last updated: March 2, 2015

Page last updated: August 23, 2015

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