Evaluation of N1539 Following Major Surgery
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Intervention: N1539; Intravenous Placebo
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 722.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pain; Analgesia; N1539; Phase 3

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

Eligibility 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.