Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Followi… (NCT04855240) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
United States239 participantsStarted 2021-03-29
Plain-language summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 Hours