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Completed

NCT Number: NCT04855240

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ACP-044 Dose A

Drug

Oral dose of ACP-044 Dose A

ACP-044 Dose B

Drug

Oral dose of ACP-044 Dose B

Placebo

Drug

Oral dose of placebo

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

    Time frame: 0-24 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.

Secondary outcomes

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

    Time frame: 0-72 hours

  2. Proportion of Subjects Who Were Opioid Free Through 24 Hours

    Time frame: 0-24 hours

  3. Proportion of Subjects Who Were Opioid Free Through 48 Hours

    Time frame: 0-48 hours

  4. Proportion of Subjects Who Were Opioid Free Through 72 Hours

    Time frame: 0-72 hours

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

    Time frame: 0-48 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, 24, 30, 36, 42, and 48 hours.

  6. Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044

    Time frame: 0-72 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, 24, 30, 36, 42, 48, 54, 60, 66, and 72 hours.

  7. Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044

    Time frame: 0-4 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, and 4 hours.

  8. Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044

    Time frame: 0-6 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, and 6 hours.

  9. Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044

    Time frame: 0-12 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, and 12 hours.

  10. Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044

    Time frame: 24-48 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): 24, 30, 36, 42, and 48 hours.

  11. Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044

    Time frame: 48-72 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): 48, 54, 60, 66, and 72 hours.

  12. Rescue Medication Taken During 0-24 Hours

    Time frame: 0-24 hours

    Number of instances of rescue medication taken during first 24 hours.

  13. Rescue Medication Taken During 24-48 Hours

    Time frame: 24-48 hours

    Number of instances of rescue medication taken during 24-48 hours.

  14. Rescue Medication Taken During 48-72 Hours

    Time frame: 48-72 hours

    Number of instances of rescue medication taken during 48-72 hours.

  15. Rescue Medication Taken During 0-48 Hours

    Time frame: 0-48 hours

    Number of instances of rescue medication taken during first 48 hours.

  16. Rescue Medication Taken During 0-72 Hours

    Time frame: 0-72 hours

    Number of instances of rescue medication taken during first 72 hours.

  17. Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours

    Time frame: 0-24 hours

  18. Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours

    Time frame: 0-48 hours

  19. Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours

    Time frame: 0-72 Hours

  20. Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours

    Time frame: 0-24 hours

  21. Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours

    Time frame: 0-48 hours

  22. Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours

    Time frame: 0-72 hours

  23. Number of Hours Subjects Are Pain Free (NRS ≤2)

    Time frame: 0-72 hours

  24. Proportion of Subjects Who Were Opioid Free During 24-48 Hours

    Time frame: 24-48 hours

  25. Proportion of Subjects Who Were Opioid Free During 48-72 Hours

    Time frame: 48-72 hours

  26. Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)

    Time frame: First rescue medication dose, up to 24 hours post first dose.

    5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent

  27. Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)

    Time frame: 24 hours

    5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent

  28. Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)

    Time frame: 48 hours

    5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent

  29. Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)

    Time frame: 72 hours

    5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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