Evaluation of Preoperative N1539 in Colorectal Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2018-09-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer

NCT02012244

Colorectal Surgery

COMPLETED NA

Effect of Ketamine on Postoperative Clinical Outcomes

NCT01365195

Colorectal Surgery

TERMINATED PHASE4

DFA-02 in Patients Undergoing Colorectal Surgery

NCT01496352

Surgical Site Infection

COMPLETED PHASE1/PHASE2

Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain

NCT02790203

Prevention of Post Operative Ileus

UNKNOWN NA

Simvastatin in Colorectal Surgery

NCT00994903

Intestinal Neoplasm Perioperative Care

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N1539 30 mg

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

Group Type EXPERIMENTAL

N1539

Intervention Type DRUG

Once Daily

IV Placebo

IV Placebo every 24 hours

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once Daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N1539

Once Daily

Intervention Type DRUG

Placebo

Once Daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intravenous meloxicam Intravenous placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No