To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
239
Oral dose of ACP-044 Dose A
Oral dose of ACP-044 Dose B
Oral dose of placebo
Anaheim Clinical Trials
Anaheim, California, United States
Chesapeake Ambulatory Surgery Center
Pasadena, Maryland, United States
Endeavor Clinical Trials of San Antonio, TX
San Antonio, Texas, United States
JBR Cinical Research
Salt Lake City, Utah, United States
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.
Time frame: 0-24 hours
Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
Time frame: 0-72 hours
Proportion of Subjects Who Were Opioid Free Through 24 Hours
Time frame: 0-24 hours
Proportion of Subjects Who Were Opioid Free Through 48 Hours
Time frame: 0-48 hours
Proportion of Subjects Who Were Opioid Free Through 72 Hours
Time frame: 0-72 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.
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Time frame: 0-48 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.
Time frame: 0-72 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.
Time frame: 0-4 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.
Time frame: 0-6 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.
Time frame: 0-12 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.
Time frame: 24-48 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.
Time frame: 48-72 hours
Rescue Medication Taken During 0-24 Hours
Number of instances of rescue medication taken during first 24 hours.
Time frame: 0-24 hours
Rescue Medication Taken During 24-48 Hours
Number of instances of rescue medication taken during 24-48 hours.
Time frame: 24-48 hours
Rescue Medication Taken During 48-72 Hours
Number of instances of rescue medication taken during 48-72 hours.
Time frame: 48-72 hours
Rescue Medication Taken During 0-48 Hours
Number of instances of rescue medication taken during first 48 hours.
Time frame: 0-48 hours
Rescue Medication Taken During 0-72 Hours
Number of instances of rescue medication taken during first 72 hours.
Time frame: 0-72 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
Time frame: 0-24 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
Time frame: 0-48 hours
Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
Time frame: 0-72 Hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
Time frame: 0-24 hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
Time frame: 0-48 hours
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
Time frame: 0-72 hours
Number of Hours Subjects Are Pain Free (NRS ≤2)
Time frame: 0-72 hours
Proportion of Subjects Who Were Opioid Free During 24-48 Hours
Time frame: 24-48 hours
Proportion of Subjects Who Were Opioid Free During 48-72 Hours
Time frame: 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
Time frame: First rescue medication dose, up to 24 hours post first dose.
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
Time frame: 24 hours
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
Time frame: 48 hours
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
Time frame: 72 hours