Evaluation of Preoperative N1539 in Colorectal Surgery

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: N1539
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily provide written informed consent. Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis. ASA physical status category 1, 2, or 3. Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study. Have a body mass index <40 kg/m^2 Exclusion Criteria: Have a known allergy or hypersensitivity to any study treatment. Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure. Have a history of myocardial infarction within the preceding 12 months. Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with exception of events related to an ulcerative colitis diagnosis. Have a known bleeding disorder which may be worsened with the administration of an NSAID. Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery. Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication. Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N1539 30 mg<br>N1539 (meloxicam injection for IV use) 30 mg every 24 hours | Drug: N1539<br>* Once Daily<br>* Other names: Intravenous meloxicam;|
| Placebo Comparator: IV Placebo<br>IV Placebo every 24 hours | Drug: Placebo<br>* Once Daily<br>* Other names: Intravenous placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Pain, Analgesia, N1539, Phase 3b