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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2022-03-14

Brief Summary

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

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Detailed Description

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Conditions

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Acute Postoperative Pain Bunionectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug - ACP-044 Dose A

ACP-044 Dose A

Group Type EXPERIMENTAL

ACP-044 Dose A

Intervention Type DRUG

Oral dose of ACP-044 Dose A

Drug - ACP-044 Dose B

ACP-044 Dose B

Group Type EXPERIMENTAL

ACP-044 Dose B

Intervention Type DRUG

Oral dose of ACP-044 Dose B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral dose of placebo

Interventions

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ACP-044 Dose A

Oral dose of ACP-044 Dose A

Intervention Type DRUG

ACP-044 Dose B

Oral dose of ACP-044 Dose B

Intervention Type DRUG

Placebo

Oral dose of placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No