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Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ACP-044 for Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy)

NCT04855240•ACADIA Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (4)

Anaheim Clinical Trials

Anaheim, California, United States

Chesapeake Ambulatory Surgery Center

Pasadena, Maryland, United States

Endeavor Clinical Trials of San Antonio, TX

San Antonio, Texas, United States

JBR Cinical Research

Salt Lake City, Utah, United States

Key Dates

Start Date

March 29, 2021

Primary Completion Date

February 11, 2022

Completion Date

March 14, 2022

Last Updated

May 3, 2023

Enrollment

239

ACTUAL participants

Conditions

Acute Postoperative PainBunionectomy

Interventions

ACP-044 Dose A

DRUG

ACP-044 Dose B

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy

Inclusion Criteria

Exclusion Criteria

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