Evaluation of Preoperative N1539 in Colorectal Surgery

This is an interventional treatment trial for Pain, Postoperative focused on measuring Colorectal surgery, Pain, Analgesia, N1539, Phase 3b Read More

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.