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Evaluation of N1539 Following Major 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.
 
ClinicalTrials.gov Identifier: NCT02720692
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Baudax Bio

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

Condition or disease Intervention/treatment Phase
Pain, Post-operative Drug: N1539 Drug: Intravenous Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arms and Interventions
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Arm Intervention/treatment
Experimental: N1539 30mg
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses.
 Drug: N1539
Other Name: Intravenous meloxicam
Placebo Comparator: IV Placebo
IV Placebo every 24 hours for up to 7 doses.
 Drug: Intravenous Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: 28 Days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • 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.
Contacts and Locations
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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): NCT02720692


Locations
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United States, Alabama
Florence, Alabama, United States, 35630
Montgomery, Alabama, United States, 36116
Sheffield, Alabama, United States, 35660
United States, Arizona
Gilbert, Arizona, United States, 85295
Phoenix, Arizona, United States, 85023
United States, California
Anaheim, California, United States, 92801
Bakersfield, California, United States, 93301
United States, Florida
Miami, Florida, United States, 33136
Tamarac, Florida, United States, 33321
Tampa, Florida, United States, 33605
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Montana
Great Falls, Montana, United States, 59405
United States, Ohio
Cleveland, Ohio, United States, 44111
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Tyrone, Pennsylvania, United States, 16686
United States, Tennessee
Hendersonville, Tennessee, United States, 37075
United States, Texas
Houston, Texas, United States, 77004
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84124
Australia, Queensland
Chermside, Queensland, Australia, 4032
Kippa-Ring, Queensland, Australia, 4021
Southport, Queensland, Australia, 4215
Australia, Victoria
Richmond, Victoria, Australia, 3121
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B#H2Y
Canada, Ontario
Kingston, Ontario, Canada, K7L2V7
Toronto, Ontario, Canada, M5T2S8
Canada, Quebec
Montreal, Quebec, Canada, H1T2M4
Montreal, Quebec, Canada, H4A3J1
New Zealand
Auckland, New Zealand
Christchurch, New Zealand, 8024
Hamilton, New Zealand, 3206
Sponsors and Collaborators
Baudax Bio
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Baudax Bio
ClinicalTrials.gov Identifier: NCT02720692    
Other Study ID Numbers: REC-15-017
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Baudax Bio:
Pain
Analgesia
N1539
Phase 3
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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