Evaluation of Preoperative N1539 in Colorectal Surgery

Summary

The primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of Adverse Events (AEs) and Serious AEs (SAEs).

Timeline

Start

2017-10-24

Primary completion

2018-09-26

Completion

2018-09-26

Publications

• Silinsky JD, Marcet JE, Anupindi VR, Karkare SU, Shah DR, Mack RJ, McCallum SW, Du W, Freyer A, Black LK. Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis. Pain Manag. 2021 Jan;11(1):9-21. doi: 10.2217/pmt-2020-0061. Epub 2020 Oct 23.

Drugs

Indications