Evaluation of Preoperative N1539 in Colorectal Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323385
• Other study ID #: REC-17-024
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2017
• Est. completion date: September 26, 2018

Study information

• Verified date: May 2023
• Source: Baudax Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• N1539
Once Daily
• Placebo
Once Daily

Locations

Country	Name	City	State
United States	Research Center	Cleveland	Ohio
United States	Research Center	Cleveland	Ohio
United States	Research Center	Columbus	Ohio
United States	Research Center	Florence	Alabama
United States	Research Center	Jackson	Mississippi
United States	Research Center	Metairie	Louisiana
United States	Research Center	Miami	Florida
United States	Research Center	Mobile	Alabama
United States	Research Center	Philadelphia	Pennsylvania
United States	Research Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baudax Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Safety and Tolerability - Number of Subjects With an AE	Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery	Up to 30 days