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Evaluation of Preoperative N1539 in Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT03323385
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : May 17, 2018
Sponsor:
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)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03323385


Contacts
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Contact: Stewart McCallum, MD 484-395-2470 ext 2411 smccallum@recropharma.com
Contact: Randall Mack 484-395-2470 ext 2406 rmack@recropharma.com

Locations
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United States, Alabama
Research Center Recruiting
Florence, Alabama, United States, 35630
Research Center Recruiting
Mobile, Alabama, United States, 36605
United States, Florida
Research Center Recruiting
Miami, Florida, United States, 33136
Research Center Recruiting
Tampa, Florida, United States, 33606
United States, Louisiana
Research Center Recruiting
Metairie, Louisiana, United States, 70006
United States, Mississippi
Research Center Recruiting
Jackson, Mississippi, United States, 39202
United States, Ohio
Research Center Recruiting
Cleveland, Ohio, United States, 44111
Research Center Recruiting
Cleveland, Ohio, United States, 44195
Research Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Recro Pharma, Inc.

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Responsible Party: Recro Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03323385     History of Changes
Other Study ID Numbers: REC-17-024
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
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
Pain
Analgesia
N1539
Phase 3b

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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