Evaluation of Preoperative N1539 in Colorectal Surgery

• Status: Completed
• Trial end date: 2018-09-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Recro Pharma, Inc.
• Treatments: Meloxicam

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.