Evaluation of Preoperative N1539 in Colorectal Surgery



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 80
Updated:5/19/2018
Start Date:October 24, 2017
End Date:August 2018
Contact:Stewart McCallum, MD
Email:smccallum@recropharma.com
Phone:484-395-2470

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

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).


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.
We found this trial at
9
sites
3800 Houma Boulevard
Metairie, Louisiana 70006
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Cleveland, Ohio 44106
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Cleveland, OH
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Columbus, Ohio 43215
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Columbus, OH
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1 Harrison Plaza
Florence, Alabama 35630
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Florence, AL
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632 Belvedere Road
Jackson, Mississippi 39202
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Jackson, MS
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Miami, Florida 33173
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Miami, FL
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Mobile, Alabama 36608
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Mobile, AL
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Philadelphia, Pennsylvania 19118
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Philadelphia, PA
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15310 Amberly Drive
Tampa, Florida 33606
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Tampa, FL
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