Back to resultsEvaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Primary Purpose
Acute Postoperative Pain, Bunionectomy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACP-044 Dose A
ACP-044 Dose B
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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).
Sites / Locations
- Anaheim Clinical Trials
- Chesapeake Ambulatory Surgery Center
- Endeavor Clinical Trials of San Antonio, TX
- JBR Cinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Drug - ACP-044 Dose A
Drug - ACP-044 Dose B
Placebo
Arm Description
ACP-044 Dose A
ACP-044 Dose B
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
Proportion of Subjects Who Were Opioid Free Through 24 Hours
Proportion of Subjects Who Were Opioid Free Through 48 Hours
Proportion of Subjects Who Were Opioid Free Through 72 Hours
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044
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.
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044
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.
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044
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.
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044
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.
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044
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.
Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044
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.
Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044
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.
Rescue Medication Taken During 0-24 Hours
Number of instances of rescue medication taken during first 24 hours.
Rescue Medication Taken During 24-48 Hours
Number of instances of rescue medication taken during 24-48 hours.
Rescue Medication Taken During 48-72 Hours
Number of instances of rescue medication taken during 48-72 hours.
Rescue Medication Taken During 0-48 Hours
Number of instances of rescue medication taken during first 48 hours.
Rescue Medication Taken During 0-72 Hours
Number of instances of rescue medication taken during first 72 hours.
Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
Number of Hours Subjects Are Pain Free (NRS ≤2)
Proportion of Subjects Who Were Opioid Free During 24-48 Hours
Proportion of Subjects Who Were Opioid Free During 48-72 Hours
Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Full Information
NCT ID
NCT04855240
First Posted
April 19, 2021
Last Updated
April 8, 2023
Sponsor
ACADIA Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04855240
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain, Bunionectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug - ACP-044 Dose A
Arm Type
Experimental
Arm Description
ACP-044 Dose A
Arm Title
Drug - ACP-044 Dose B
Arm Type
Experimental
Arm Description
ACP-044 Dose B
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ACP-044 Dose A
Intervention Description
Oral dose of ACP-044 Dose A
Intervention Type
Drug
Intervention Name(s)
ACP-044 Dose B
Intervention Description
Oral dose of ACP-044 Dose B
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral dose of placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
Time Frame
0-72 hours
Title
Proportion of Subjects Who Were Opioid Free Through 24 Hours
Time Frame
0-24 hours
Title
Proportion of Subjects Who Were Opioid Free Through 48 Hours
Time Frame
0-48 hours
Title
Proportion of Subjects Who Were Opioid Free Through 72 Hours
Time Frame
0-72 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044
Description
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.
Time Frame
0-48 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044
Description
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.
Time Frame
0-72 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044
Description
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.
Time Frame
0-4 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044
Description
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.
Time Frame
0-6 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044
Description
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.
Time Frame
0-12 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044
Description
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.
Time Frame
24-48 hours
Title
Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044
Description
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.
Time Frame
48-72 hours
Title
Rescue Medication Taken During 0-24 Hours
Description
Number of instances of rescue medication taken during first 24 hours.
Time Frame
0-24 hours
Title
Rescue Medication Taken During 24-48 Hours
Description
Number of instances of rescue medication taken during 24-48 hours.
Time Frame
24-48 hours
Title
Rescue Medication Taken During 48-72 Hours
Description
Number of instances of rescue medication taken during 48-72 hours.
Time Frame
48-72 hours
Title
Rescue Medication Taken During 0-48 Hours
Description
Number of instances of rescue medication taken during first 48 hours.
Time Frame
0-48 hours
Title
Rescue Medication Taken During 0-72 Hours
Description
Number of instances of rescue medication taken during first 72 hours.
Time Frame
0-72 hours
Title
Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
Time Frame
0-24 hours
Title
Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
Time Frame
0-48 hours
Title
Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
Time Frame
0-72 Hours
Title
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
Time Frame
0-24 hours
Title
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
Time Frame
0-48 hours
Title
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
Time Frame
0-72 hours
Title
Number of Hours Subjects Are Pain Free (NRS ≤2)
Time Frame
0-72 hours
Title
Proportion of Subjects Who Were Opioid Free During 24-48 Hours
Time Frame
24-48 hours
Title
Proportion of Subjects Who Were Opioid Free During 48-72 Hours
Time Frame
48-72 hours
Title
Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)
Description
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time Frame
First rescue medication dose, up to 24 hours post first dose.
Title
Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
Description
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time Frame
24 hours
Title
Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
Description
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time Frame
48 hours
Title
Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
Description
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Chesapeake Ambulatory Surgery Center
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Endeavor Clinical Trials of San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
JBR Cinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
We'll reach out to this number within 24 hrs