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
Stopped early · Phase 3
Conditions studied: Post Operative Pain
In brief
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.
Key facts
- Study ID
- NCT02381132
- Run by
- Neil Singla
- People needed
- 99
- Starts
- 2014-11-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-03-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Lotus Clinical Research, LLC — Pasadena, California, United States
Full record on ClinicalTrials.gov
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