Evaluation of Preoperative N1539 in Colorectal Surgery

Baudax Bio

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Placebo; Drug: N1539

Study type: Interventional

Funder types: Industry

Identifiers

NCT03323385

REC-17-024

Details and patient eligibility

About

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).

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

N1539 30 mg

Experimental group

Description:

N1539 (meloxicam injection for IV use) 30 mg every 24 hours

Treatment:

Drug: N1539

IV Placebo

Placebo Comparator group

Description:

IV Placebo every 24 hours

Treatment:

Drug: Placebo