Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ACADIA Pharmaceuticals Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
