Evaluation of Preoperative N1539 in Colorectal Surgery

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

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Placebo; Drug: N1539

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Florence, Alabama, United States, 35630
      • Research Center
    • Mobile, Alabama, United States, 36605
      • Research Center
  • Florida
    • Miami, Florida, United States, 33136
      • Research Center
    • Tampa, Florida, United States, 33606
      • Research Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Research Center
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Research Center
  • Ohio
    • Cleveland, Ohio, United States, 44111
      • Research Center
    • Cleveland, Ohio, United States, 44195
      • Research Center
    • Columbus, Ohio, United States, 43210
      • Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N1539 30 mg; N1539 (meloxicam injection for IV use) 30 mg every 24 hours	Drug: N1539; Once Daily; Other Names: Intravenous meloxicam
Placebo Comparator: IV Placebo; IV Placebo every 24 hours	Drug: Placebo; Once Daily; Other Names: Intravenous placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baudax Bio

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Colorectal surgery; Phase 3b; N1539
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: REC-17-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No