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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Research Center
Florence, Alabama, United States
Research Center
Mobile, Alabama, United States
Research Center
Miami, Florida, United States
Research Center
Tampa, Florida, United States
Evaluation of Safety and Tolerability - Number of Subjects With an AE
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
Time frame: Up to 30 days
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Research Center
Metairie, Louisiana, United States
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Jackson, Mississippi, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States