Clinical trial NCT04855240: Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Postoperative Pain
Bunionectomy
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: 0-24 hours
Secondary outcomes:
measure: Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
timeFrame: 0-72 hours
measure: Proportion of Subjects Who Were Opioid Free Through 24 Hours
timeFrame: 0-24 hours
measure: Proportion of Subjects Who Were Opioid Free Through 48 Hours
timeFrame: 0-48 hours
measure: Proportion of Subjects Who Were Opioid Free Through 72 Hours
timeFrame: 0-72 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044
timeFrame: 0-48 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044
timeFrame: 0-72 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044
timeFrame: 0-4 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044
timeFrame: 0-6 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044
timeFrame: 0-12 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044
timeFrame: 24-48 hours
measure: Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044
timeFrame: 48-72 hours
measure: Rescue Medication Taken During 0-24 Hours
timeFrame: 0-24 hours
measure: Rescue Medication Taken During 24-48 Hours
timeFrame: 24-48 hours
measure: Rescue Medication Taken During 48-72 Hours
timeFrame: 48-72 hours
measure: Rescue Medication Taken During 0-48 Hours
timeFrame: 0-48 hours
measure: Rescue Medication Taken During 0-72 Hours
timeFrame: 0-72 hours
measure: Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
timeFrame: 0-24 hours
measure: Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
timeFrame: 0-48 hours
measure: Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
timeFrame: 0-72 Hours
measure: Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
timeFrame: 0-24 hours
measure: Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
timeFrame: 0-48 hours
measure: Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
timeFrame: 0-72 hours
measure: Number of Hours Subjects Are Pain Free (NRS ≤2)
timeFrame: 0-72 hours
measure: Proportion of Subjects Who Were Opioid Free During 24-48 Hours
timeFrame: 24-48 hours
measure: Proportion of Subjects Who Were Opioid Free During 48-72 Hours
timeFrame: 48-72 hours
measure: Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)
timeFrame: First rescue medication dose, up to 24 hours post first dose.
measure: Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
timeFrame: 24 hours
measure: Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
timeFrame: 48 hours
measure: Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Pasadena
country: United States
facility: Chesapeake Ambulatory Surgery Center
state: Maryland
city: San Antonio
country: United States
facility: Endeavor Clinical Trials of San Antonio, TX
state: Texas
city: Salt Lake City
country: United States
facility: JBR Cinical Research
state: Utah
Study officials:
References: