Overview
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Status:
Recruiting
Recruiting
Trial end date:
2021-11-01
2021-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative painPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
ACADIA Pharmaceuticals Inc.
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).