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

NCT04855240 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ACP-044-004
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Acute Postoperative Pain; Bunionectomy

Outcome Measures

Primary Outcomes (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

  Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24 hours.

  0-24 hours

Secondary Outcomes (29)

• Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)

  0-72 hours

• Proportion of Subjects Who Were Opioid Free Through 24 Hours

  0-24 hours

• Proportion of Subjects Who Were Opioid Free Through 48 Hours

  0-48 hours

• Proportion of Subjects Who Were Opioid Free Through 72 Hours

  0-72 hours

• Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044

  0-48 hours

Study Arms (3)

Drug - ACP-044 Dose A

EXPERIMENTAL

ACP-044 Dose A

Drug: ACP-044 Dose A

Drug - ACP-044 Dose B

EXPERIMENTAL

ACP-044 Dose B

Drug: ACP-044 Dose B

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ACP-044 Dose A DRUG

Oral dose of ACP-044 Dose A

Drug - ACP-044 Dose A

ACP-044 Dose B DRUG

Oral dose of ACP-044 Dose B

Drug - ACP-044 Dose B

Placebo DRUG

Oral dose of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (4)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Chesapeake Ambulatory Surgery Center

Pasadena, Maryland, 21122, United States

Location

Endeavor Clinical Trials of San Antonio, TX

San Antonio, Texas, 78229, United States

Location

JBR Cinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Acadia Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

844-422-2342

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: March 29, 2021
• Primary Completion: February 11, 2022
• Study Completion: March 14, 2022
• Last Updated: May 3, 2023
• Results First Posted: May 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)