Evaluation of N1539 Following Bunionectomy 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: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bunion; Bunionectomy; Pain; Analgesia; N1539; Phase 3

Summary:

      The primary objective of this study is to evaluate the analgesic efficacy of N1539 in
      subjects with acute moderate to severe pain following unilateral bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent.

          -  Male or female between 18 and 75 years of age, inclusive.

          -  Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair

          -  Be American Society of Anesthesiology (ASA) physical class 1 or 2.

          -  Female subject are eligible only if all the following apply:

               -  Not pregnant;

               -  Not lactating;

               -  Not planning to become pregnant during the study;

               -  Commit to the use of an acceptable form of birth control for the duration of the
                  study.

          -  Have a body mass index ≤35 kg/m2

          -  Be able to understand the study procedures, comply with all study procedures, and
             agree to participate in the study program.

        Exclusion Criteria:

          -  Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other
             non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative
             medications used in this study.

          -  Have a clinically significant abnormal clinical laboratory test value.

          -  Have history of or positive test results for HIV, or hepatitis B or C.

          -  Have a history or clinical manifestations of significant renal, hepatic,
             cardiovascular, metabolic, neurologic, psychiatric, or other condition that would
             preclude participation in the study.

          -  Have a history of myocardial infarction or coronary artery bypass graft surgery within
             the preceding 12 months

          -  Have a history of migraine or frequent headaches, seizures, or are currently taking
             anticonvulsants.

          -  Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

          -  Have a known bleeding disorder or be taking agents affecting coagulation

          -  Have another painful physical condition that may confound the assessments of post
             operative pain.

          -  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) within the past 5 years or a history of
             prescription/illicit drug abuse.

          -  Have positive results on the urine drug screen or alcohol breath test indicative of
             illicit drug or alcohol abuse.

          -  Have been receiving or have received chronic opioid therapy defined as greater than 15
             morphine equivalents units per day for greater than 3 out of 7 days per week over a
             one-month period within 12 months of surgery.

          -  Use concurrent therapy that could interfere with the evaluation of efficacy or safety,
             such as any drugs which in the investigator's opinion may exert significant analgesic
             properties or act synergistically with N1539.

          -  Unable to discontinue medications, that have not been at a stable dose for at least 14
             days prior to the scheduled bunionectomy 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.

          -  Have utilized corticosteroids, either systemically or by intra-articular injection,
             within 6 weeks prior to the surgical procedure.

          -  Have received any investigational product within 30 days before dosing with study
             medication.

          -  Be receiving warfarin, 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®) within 7 days prior to
             surgery

          -  Have previously received N1539 in clinical trials, or had major surgery in the last 3
             months that would interfere with study outcomes or increase the risk of study
             participation.