Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Condition: Acute Postoperative Pain; Bunionectomy
MeSH terms: Pain, Postoperative
Intervention: ACP-044 Dose A; ACP-044 Dose B; Placebo
Intervention description: Oral dose of ACP-044 Dose A; Oral dose of ACP-044 Dose B; Oral dose of placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute
      postoperative pain
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 and <60 years of age at the time of Screening

          -  Has a body mass index (BMI) <40 kg/m2

          -  Able to understand and provide signed informed consent

          -  Able to complete subject-reported outcome measures

          -  Is in need of a primary unilateral, first metatarsal bunionectomy with osteotomy and
             internal fixation under regional anesthesia and sedation

          -  Willing to remain inpatient at the study center for 4 days following surgery

        Exclusion Criteria:

          -  Has had a contralateral foot bunionectomy in the past 3 months

          -  Has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral
             procedures like hammertoe correction on the surgical foot)

          -  Any subacute or chronic pain condition or use of a medication that would impair/impact
             the ability to rate the pain associated with the bunionectomy, in the opinion of the
             Investigator and Medical Monitor

          -  Has known or suspected regular use of opioids within the previous 6 months

          -  Has taken opioids within 24 hours prior to the scheduled surgery or within five
             half-lives of the drug, whichever is longer

          -  Has a known or suspected history of drug abuse, a positive drug screen at Screening or
             Day -1, or a recent (i.e., within the last 5 years) history of alcohol abuse. Subjects
             using marijuana are not allowed to participate in the study.

          -  Has taken any aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2
             days prior to the scheduled surgery or within five half-lives of the drug, whichever
             is longer

          -  Has initiated treatment with any medications within 1 month prior to study drug
             administration that could impact pain control or quantitation of their pain response

          -  Has been administered systemic steroids within five half-lives or 10 days prior to
             administration of study drug, whichever is longer

          -  Has current evidence, or medical history of a serious and/or unstable psychiatric,
             neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic,
             hematologic, endocrinologic, or other medical disorder, within the previous 12 weeks
             prior to Screening and on Day -1, that in the judgment of the Investigator and/or
             Medical Monitor would jeopardize the safe participation of the subject in the study.
             Also, subject must not have had a malignancy in the last year, with the exception of
             nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix.

          -  Is judged by the Investigator or the Medical Monitor to be inappropriate for the study

        Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to
        ensure that all criteria for study participation are met. Patients may be excluded from the
        study based on these assessments (and specifically, if it is determined that their baseline
        health and psychiatric condition do not meet all pre-specified entry criteria).