Clinical trial NCT03323385: Evaluation of Preoperative N1539 in Colorectal Surgery
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Colorectal surgery
Pain
Analgesia
N1539
Phase 3b
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2017-10-27
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 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.

Primary outcomes:
measure: Evaluation of Safety and Tolerability - Number of Subjects With an AE
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: United States
facility: Research Center
state: Alabama
city: Mobile
country: United States
facility: Research Center
state: Alabama
city: Miami
country: United States
facility: Research Center
state: Florida
city: Tampa
country: United States
facility: Research Center
state: Florida
city: Metairie
country: United States
facility: Research Center
state: Louisiana
city: Jackson
country: United States
facility: Research Center
state: Mississippi
city: Cleveland
country: United States
facility: Research Center
state: Ohio
city: Cleveland
country: United States
facility: Research Center
state: Ohio
city: Columbus
country: United States
facility: Research Center
state: Ohio
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
Study officials:
References:
citation: 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.