Evaluation of N1539 Following Major Surgery

May 25, 2023 updated by: Baudax Bio

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery

The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Chermside, Queensland, Australia, 4032
      • Kippa-Ring, Queensland, Australia, 4021
      • Southport, Queensland, Australia, 4215
    • Victoria
      • Richmond, Victoria, Australia, 3121
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B#H2Y
    • Ontario
      • Kingston, Ontario, Canada, K7L2V7
      • Toronto, Ontario, Canada, M5T2S8
    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
      • Montreal, Quebec, Canada, H4A3J1
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand, 8024
      • Hamilton, New Zealand, 3206
  • United States
    • Alabama
      • Florence, Alabama, United States, 35630
      • Montgomery, Alabama, United States, 36116
      • Sheffield, Alabama, United States, 35660
    • Arizona
      • Gilbert, Arizona, United States, 85295
      • Phoenix, Arizona, United States, 85023
    • California
      • Anaheim, California, United States, 92801
      • Bakersfield, California, United States, 93301
    • Florida
      • Miami, Florida, United States, 33136
      • Tamarac, Florida, United States, 33321
      • Tampa, Florida, United States, 33605
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Montana
      • Great Falls, Montana, United States, 59405
    • Ohio
      • Cleveland, Ohio, United States, 44111
      • Columbus, Ohio, United States, 43210
    • Pennsylvania
      • Tyrone, Pennsylvania, United States, 16686
    • Tennessee
      • Hendersonville, Tennessee, United States, 37075
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77004
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily provide written informed consent.
  • Male or female between 18 and 80 years of age, inclusive.
  • Be planning to undergo major elective surgery, and be expected to require intravenous analgesia and remain in an inpatient setting for at least 24-48 hours and are expected to receive at least two study doses.

  • Female subjects are eligible only if all the following apply:

    • Not pregnant;
    • Not breastfeeding;
    • Not able to become pregnant;
    • Not planning to become pregnant during the study or 28 day follow up;
    • Commit to the use of an acceptable form of birth control for the duration of the study.
  • Have a body mass index ≤40 kg/m2
  • Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
  • For oncology cases, have a histologically confirmed diagnosis of a primary solid tumor, affecting any one of the following organs: breast, skin, colon, prostate, uterus, ovaries, urethra, penis, or vulva; AND based on clinical, laboratory, radiologic, pathologic, and surgical findings, the tumor is confined to the primary organ, without evidence of local, regional or distal spread; AND have a performance status such that they are able to carry on normal activities of daily life without limitations.

Exclusion Criteria:

  • Have a known allergy to meloxicam or any excipient of N1539, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Be scheduled to undergo cranial surgery, open heart procedure, any type of coronary artery bypass graft, organ transplant, or any other surgical procedure in which NSAIDs are contraindicated.
  • Planned or actual admission to the intensive care unit at any time during study participation.
  • Have clinically significant laboratory abnormalities.
  • Have a history of myocardial infarction within the preceding 12 months.
  • Have history of HIV, or hepatitis B or C.
  • Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, respiratory, or other condition that would preclude participation in the study.
  • Have active or recent (within 6 months) gastrointestinal ulceration or bleeding
  • Have a known bleeding disorder which may be worsened with the administration of a NSAID.
  • Have evidence of a clinically significant 12 lead ECG abnormality.
  • Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or a history of prescription/illicit drug abuse within the past 5 years.
  • Have positive results on the urine drug screen for cocaine or PCP or alcohol breath test indicative of illicit drug or alcohol abuse.
  • Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled surgical procedure, within 5 half-lives of the specific prior medication (or, if half-life is not known, within 48 hours) before dosing with study medication.
  • Be unable to discontinue herbal medications at least 7 days prior to surgery through last dose of study medication.
  • Be receiving lithium, or a combination of furosemide with either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker
  • Be currently receiving treatment with oral meloxicam (Mobic®) or other NSAID within 7 days prior to surgery.
  • Have received any investigational product within 30 days before dosing with study medication.
  • Have previously received N1539 in clinical trials, or had major surgery in the last 3 months that would interfere with study assessments.
  • Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening, through the last study visit, approximately 30 days after dosing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N1539 30mg
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses.
Drug: N1539
Other Names:
  • Intravenous meloxicam
Placebo Comparator: IV Placebo
IV Placebo every 24 hours for up to 7 doses.
Drug: Intravenous Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Adverse Events
Time Frame: 28 Days
Number of subjects reporting 1 or more treatment-emergent adverse events
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Opioid Use
Time Frame: Up to 7 days
Postoperative opioid use was measured throughout the inpatient phase and converted to the total IV morphine equivalent dose
Up to 7 days
Investigator Satisfaction With Surgical Wound Healing
Time Frame: Up to 7 days after last study dose
Investigators assessed their satisfaction with the healing of the surgical wound according to an 11-point numeric rating scale (0-10) where a score of 0 was completely unsatisfied (worse outcome), and a score of 10 was completely satisfied (better outcome).
Up to 7 days after last study dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baudax Bio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimated)

March 28, 2016

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-15-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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