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Evaluation of Preoperative N1539 in Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03323385
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : November 13, 2019
Information provided by (Responsible Party):
Recro Pharma, Inc.

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

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Study Type : Interventional  (Clinical Trial)
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 : October 24, 2017
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: N1539 30 mg
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
Drug: N1539
Once Daily
Other Name: Intravenous meloxicam

Placebo Comparator: IV Placebo
IV Placebo every 24 hours
Drug: Placebo
Once Daily
Other Name: Intravenous placebo

Primary Outcome Measures :
  1. Evaluation of Safety and Tolerability [ Time Frame: Up to 30 days ]
    Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03323385

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United States, Alabama
Research Center
Florence, Alabama, United States, 35630
Research Center
Mobile, Alabama, United States, 36605
United States, Florida
Research Center
Miami, Florida, United States, 33136
Research Center
Tampa, Florida, United States, 33606
United States, Louisiana
Research Center
Metairie, Louisiana, United States, 70006
United States, Mississippi
Research Center
Jackson, Mississippi, United States, 39202
United States, Ohio
Research Center
Cleveland, Ohio, United States, 44111
Research Center
Cleveland, Ohio, United States, 44195
Research Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Research Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Recro Pharma, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Recro Pharma, Inc. Identifier: NCT03323385    
Other Study ID Numbers: REC-17-024
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Recro Pharma, Inc.:
Colorectal surgery
Phase 3b
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action