Evaluation of Preoperative N1539 in Colorectal Surgery

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: N1539; Drug: Placebo

• Registration Number: NCT03323385
• Lead Sponsor: Baudax Bio

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-24
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-27
• Primary Completion: 2018-09-26
• Study Completion: 2018-09-26
• Status Verified: 2023-05
• Results First Submitted: 2023-05-25
• Results First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Results First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N1539 30 mg	N1539	N1539 (meloxicam injection for IV use) 30 mg every 24 hours
IV Placebo	Placebo	IV Placebo every 24 hours

Primary Outcome Measures

Name	Time	Method
Evaluation of Safety and Tolerability - Number of Subjects With an AE	Up to 30 days	Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery

Trial Locations

Locations (1)

Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States