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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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