Status:
COMPLETED
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Lead Sponsor:
ACADIA Pharmaceuticals Inc.
Conditions:
Acute Postoperative Pain
Bunionectomy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04855240
Start Date
March 29 2021
End Date
March 14 2022
Last Update
May 3 2023
Active Locations (4)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
Chesapeake Ambulatory Surgery Center
Pasadena, Maryland, United States, 21122
3
Endeavor Clinical Trials of San Antonio, TX
San Antonio, Texas, United States, 78229
4
JBR Cinical Research
Salt Lake City, Utah, United States, 84107