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

Acadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Bunionectomy; Acute Postoperative Pain

Treatments: Drug: ACP-044 Dose A; Drug: ACP-044 Dose B; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04855240

ACP-044-004

Details and patient eligibility

About

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

Enrollment: 239 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

239 participants in 3 patient groups, including a placebo group

Drug - ACP-044 Dose A

Experimental group

Description:

ACP-044 Dose A

Treatment:

Drug: ACP-044 Dose A

Drug - ACP-044 Dose B

Experimental group

Description:

ACP-044 Dose B

Treatment:

Drug: ACP-044 Dose B

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo