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

Baudax Bio1 site in 1 country57 target enrollmentOctober 24, 2017

ConditionsPain, Postoperative

InterventionsN1539 Placebo

DrugsN1539 Placebo

Overview

Phase: Phase 3
Intervention: N1539
Conditions: Pain, Postoperative
Sponsor: Baudax Bio
Enrollment: 57
Locations: 1
Primary Endpoint: Evaluation of Safety and Tolerability - Number of Subjects With an AE
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 24, 2017

End Date

September 26, 2018

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baudax Bio

Responsible Party

Sponsor

Eligibility Criteria

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
•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.