Evaluation of Preoperative N1539 in Colorectal Surgery

Sponsor

Baudax Bio (Industry)

Overall Status

Completed

CT.gov ID

NCT03323385

Collaborator

(none)

Enrollment

Locations

Arms

11.1

Actual Duration (Months)

5.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: N1539 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 24, 2017

Actual Primary Completion Date :

Sep 26, 2018

Actual Study Completion Date :

Sep 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N1539 30 mg N1539 (meloxicam injection for IV use) 30 mg every 24 hours	Drug: N1539 Once Daily Other Names: Intravenous meloxicam
Placebo Comparator: IV Placebo IV Placebo every 24 hours	Drug: Placebo Once Daily Other Names: Intravenous placebo

Arm

Intervention/Treatment

Experimental: N1539 30 mg

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

Drug: N1539

Once Daily

Other Names:

Intravenous meloxicam

Placebo Comparator: IV Placebo

IV Placebo every 24 hours

Drug: Placebo

Once Daily

Other Names:

Intravenous placebo

Outcome Measures

Primary Outcome Measures

Evaluation of Safety and Tolerability [Up to 30 days]
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Florence	Alabama	United States	35630
2	Research Center	Mobile	Alabama	United States	36605
3	Research Center	Miami	Florida	United States	33136
4	Research Center	Tampa	Florida	United States	33606
5	Research Center	Metairie	Louisiana	United States	70006
6	Research Center	Jackson	Mississippi	United States	39202
7	Research Center	Cleveland	Ohio	United States	44111
8	Research Center	Cleveland	Ohio	United States	44195
9	Research Center	Columbus	Ohio	United States	43210
10	Research Center	Philadelphia	Pennsylvania	United States	19140